Which Medical Device | News

SIR-Spheres Y-90 Resin Microspheres Are a Well-Tolerated Alternative to Standard Therapies

Fri, 01 Apr 2016 00:00:00 GMT

SIR-Spheres® Y-90 Resin Microspheres Are a Well-Tolerated Alternative to Standard Therapies for Inoperable Primary Liver Cancer, New UK NICE Medtech Innovation Briefing Says

PR Newswire

Read more here

Bioabsorbable PerQseal Vivasure Large Bore Femoral Closure Device Cleared in EU

Sun, 31 Jan 2016 00:00:00 GMT

The Vivasure is designed to address fairly large arterial cuts created when delivering transcatheter heart valves and performing endovascular abdominal aortic aneurysm repairs.

Read the full medGadget article here.

Contego Medical's Paladin Carotid Postdilation Balloon System Launched in Europe

Sun, 31 Jan 2016 00:00:00 GMT

The Paladin device features the company’s Integrated Embolic Protection (IEP) technology. IEP combines embolic protection and treatment into one device to aim to simplify the procedure and improve patient outcomes.

Read the full Endovascular Today article here

Treatment results of Sir-Spheres Y-90 regardless of age

Mon, 25 Jan 2016 00:00:00 GMT

Vascular stent useful for CV lesions in children, long-term follow-up needed

Mon, 05 Oct 2015 00:00:00 GMT

Read the full article here.

Essential Medical Inc. Announces Successful Additional Clinical Studies For MANTA Large Bore Vascular Closure Device

Mon, 31 Aug 2015 00:00:00 GMT

PRNewswire reported that Essential Medical, Inc., a privately held medical device company, announced that it has successfully completed additional clinical studies using its MANTA 14F Large Bore Vascular Closure device, a revolutionary vascular closure device designed to seal both 14F and 18F large bore femoral punctures.

Essential Medical, Inc. Announces CE Mark Approval for New Vascular Closure Device, X-Seal

Mon, 31 Aug 2015 00:00:00 GMT

PRNewswire reported that Essential Medical, Inc., a privately held medical device company, announced that it has received CE mark approval for X-Seal™, a vascular closure device with superior handling and closure features.

Sirflox Study Abstract released by ASCO

Sat, 30 May 2015 00:00:00 GMT

The SIRFLOX study was designed to assess the efficacy and safety of combining FOLFOX chemotherapy (± bev) with SIRT using yttrium-90 (Y-90) resin microspheres as first-line treatment of pts with liver metastases from mCRC.

Read the abstract here

SIR-Spheres y-90 Resin Microspheres Recommended in New European Society of Medical Oncology (ESMO)

Thu, 02 Apr 2015 00:00:00 GMT

Newly published European Society for Medical Oncology (ESMO) clinical guidelines for the treatment of metastatic colorectal cancer (mCRC) endorse radioembolisation, specifically with Yttrium-90 resin microspheres, as a clinically proven technology to \"prolong time to liver tumour progression\" in mCRC patients who have failed to respond to available chemotherapy options.

Read full story here

Source: http://www.prnewswire.com/

FOXFIRE and FOXFIRE Global Studies Complete Patient Enrolment

Wed, 01 Apr 2015 00:00:00 GMT

Combined data from more than 1,000 patients being collected to assess overall survival (OS) benefit of adding first-line SIR-Spheres® Y-90 resin microspheres treatment to a current chemotherapy regimen for inoperable metastatic colorectal cancer (mCRC)

Read the full story here

Source www.prnewswire.com

Preliminary results of SIRFLOX show study did not achieve primary endpoint

Wed, 01 Apr 2015 00:00:00 GMT

In the first-line treatment of non-resectable metastatic colorectal cancer, the preliminary analysis of the SIRFLOX study results does not show a statistically significant improvement in overall progression-free survival ie, at any site. However, the study does show a statistically significant improvement in progression-free survival in the liver.

Read the story here

Source www.cxvascular.com

Preliminary results of SIRFLOX show study did not achieve primary endpoint

Wed, 01 Apr 2015 00:00:00 GMT

Read the release here

Source www.cxvascular.com

Sirtex Announces FOXFIRE and FOXFIRE Global Studies

Wed, 01 Apr 2015 00:00:00 GMT

Sirtex Medical Limited has announced it completed patient enrolment in FOXFIRE and FOXFIRE Global, two large-scale multi-centre clinical trials that combine liver-directed radiation therapy with SIR-Spheres Y-90 resin microspheres to a chemotherapy regimen in over 560 inoperable metastatic colorectal cancer (mCRC) patients.

Read the story here

Source http://radiationtherapynews.com/

Sirtex Reports Preliminary SIRFLOX Study Results

Wed, 01 Apr 2015 00:00:00 GMT

Sirtex Medical Limited (ASX: SRX) is pleased to report the preliminary results of its SIRFLOX clinical study.
Based on the preliminary analysis just completed, the primary endpoint of the SIRFLOX study was not achieved. The preliminary analysis shows that adding SIR-Spheres® Y-90 resin microspheres to a current first-line systemic chemotherapy regimen for the treatment of non-resectable metastatic colorectal cancer (mCRC) does not result in a statistically significant improvement in the overall Progression-Free Survival (PFS). Overall PFS measures progression of existing tumours and/or the development of new tumours in any organ or body site.

Read full story here

Source http://www.prnewswire.co.uk/

SARAH Study

Thu, 26 Mar 2015 00:00:00 GMT

The SARAH Study, a large French study of patients with advanced, inoperable hepatocellular carcinoma, has completed enrollment with more than 400 patients and expects results to be available in 2016, according to a press release.

Read the press release here

Source: www.helio.com

FOXFIRE UPDATE

Thu, 26 Mar 2015 00:00:00 GMT

FOXFIRE UPDATE

Recruitment to FOXFIRE has now closed. Thank you to all of the sites who contributed in recruiting patients to the trial. The final total was 364; this is a fantastic achievement and will allow the overall survival statistic to be answered.

Read the story here

Source: Oncology Clinical Trials Office

Hyaluronic Acid Injection in the Treatment of Small Joint Arthritis in the Hand

Wed, 18 Feb 2015 00:00:00 GMT

Article submitted by: Mr Antonios Mitsakos, SpR in Plastics and Hand Surgery, Chelsea and Westminster Hospital & Mr Maxim Horwitz, Consultant Hand Surgeon, Chelsea and Westminster Hospital

No conflict declared.

Osteoarthritis (OA) is the most common joint disease worldwide. According to the American College of Rheumatology, approximately 70 % of people over the age of 70 have radiographic evidence of osteoarthritis, though only half develop symptoms⁽¹⁾. OA can be defined as a degenerative disorder caused by the biochemical breakdown of joint cartilage. However, OA affects not only cartilage but also the entire joint, including subchondral bone and synovium. OA mostly affects weight bearing joints (knees, hips, spine and feet), but can also involve the small joints of the hand such as the distal interphalangeal (DIPJ), proximal interphalangeal (PIPJ) and carpometacarpal joints (CMCJ) of the thumb in particular. Both abnormal mechanics and inflammation have important roles in the development of OA. The diagnosis of OA is based on clinical findings with confirmation from radiographic studies rather than laboratory abnormalities.

In early OA there is swelling of the articular cartilage with subsequent attempted chondrocyte repair. This stage can last for many years, and leads to hypertrophic repair of the cartilage. This progresses to softening and loss of elasticity of cartilage. In due course, loss of the cartilage leads to loss of the joint space and exposure of underlying bone.

OA is treated with physical therapy and splintage, lifestyle adaptation, analgesia and/or surgery. Surgical approaches to the small joints of the hand include excision arthroplasty, arthrodesis or joint replacement. Drugs for OA can be administered orally or by intra-articular injection. Although corticosteroids are often given as intra-articular injections, there is evidence that injections with hyaluronic acid (HA)⁽²⁾ are as effective as steroids and can be repeated more often⁽³⁾. Synovial fluid is essential for the normal function of the joint: it acts both as a lubricant during slow movement and as an elastic shock absorber when movement is rapid. It also delivers nutrition, and transmits cellular signals to the articular cartilage⁽⁴⁾.

HA is produced by synoviocytes, fibroblasts and chondrocytes⁽⁵⁾ and is the major chemical component of synovial fluid. HA is a natural polysaccharide of high molecular weight, composed of a linear chain of disaccharide units made by sodium glucuronate and N-acetylglucosamine and is widely distributed in body tissues. Natural hyaluronic acid has a molecular weight of 4 – 10 million Daltons, and its concentration in the articular fluid is about 0.35g /100 ml⁽⁶⁾. Its high viscosity gives it viscoelastic properties, and it also protects articular cartilage and soft tissue joint surfaces⁽⁷⁾.

Beneficial effects of HA include^{(8),(9),(10),(11),(12)}:

-Inhibition of the lymphocyte transformation that promotes phagocytic activity of macrophages and leukocytes.

-Reduction of adenosine triphosphate and matrix metalloproteinase levels, thereby slowing joint destruction.

-Promotion of prostaglandin release and the normalisation of native HA synthesis⁽¹³⁾

-Acceleration of proteoglycan synthesis by chondrocytes and tissue inhibitor MMP-1 and the collection of free radicals.

-Modification of the structure of cartilage with effects on chondrocytes and cartilage explants, interleukin 1 and oxygen-derived free radicals.

There is some debate about whether high molecular weight HA is more effective than low molecular weight HA. The greater biological activity of high molecular weight HA preparations have only been shown in vitro and not confirmed in clinical trials. Some authors prefer high molecular weight HA preparations because they have a longer half-life and therefore the number of treatments needed is reduced.

Injection Technique

The intra–articular injection of HA must be performed in a clean environment to minimize the risk of infection.

The use of image guidance is recommended: when injection is performed blindly into the tight small joints of the hand, the failure rate is high and the drug may be infiltrated into the periarticular spaces. This can lead to pain and swelling as well as ineffective treatment.

Ultrasound is a fast, fairly simple, safe and economical technique with advantages over fluoroscopy: it is suitable for patients with sensitivity or intolerance to radiographic contrast media, and no ionizing radiation is involved.

The following products can be used for the injection of the small joints of the hand. Note that the volume needed for a joint is usually no more than 1ml.

GO-ON®

A syringe of GO-ON® contains: 2.5 ml of 1% sodium hyaluronate solution, sodium chloride, sodium monohydrogen phosphate, sodium dihydrogen phosphate and water for injection. It is indicated for use as a viscoelastic supplementation for synovial fluid in joints. The product acts as a lubricant and also provides mechanical support , making it suitable for treatment of the symptoms of OA.

Interactions with Other Agents: There are no reports of incompatibilities of GO-ONÂ® with other solutions for intra-articular administration. The patient may benefit from oral analgesic or anti-inflammatory agents during treatment.

Side effects: Some patients develop a skin rash. In such cases, it is advised to discontinue administration and treat the reaction. Pain (mainly transient pain after administration), swelling and effusion, as well as infection, at the injection site have rarely been reported. A few patients have complained of erythema, heat sensation and heaviness at the injection site.

Hyalgan®

Hyalgan® was the first viscosupplement approved by the FDA in 1997. It contains a high molecular weight fraction of purified natural sodium hyaluronate, extracted from rooster combs. It comes in a 5-injection regimen given weekly providing pain relief for up to 6 months. Some patients benefit from the first three injections given at weekly intervals.

The preparation has not been found to interfere with any other medication for osteoarthritis or any other medical condition. It has also been proven safe for repeat treatment if needed.

It is contraindicated in patients with hypersensitivity to hyaluronic acid preparations. Intra-articular injections are contraindicated in cases of already infected skin or in presence of skin disease at the injection site to reduce the potential for developing septic arthritis. Patients are encouraged to avoid any strenuous or prolonged activities involving their hands for the first 48 hours after the intra-articular injection.

SYNVISC®

Synvisc® is an elastoviscous fluid of high molecular weight, containing hylan A and hylan B polymers produced from chicken combs. Hylan A and B are derivatives of hyaluronic acid. It is indicated for the relief from pain in osteoarthritis (OA) in patients who have not responded satisfactorily to conservative non-pharmacologic therapy.

Synvisc® comes in two different formulations, SYNVISC® and SYNVISC-One®. SYNVISC-One® is a single dose treatment, compared with the three injections required with SYNVISC.

As with other preparations, it should not be administered to patients with infected joints, with active skin disease or with any skin infection around the area where the injection will be given. Reported side effects include (<2% each): pain, swelling, heat, redness, and/or oedema around the joint.

ORTHOVISC®

Orthovisc® is a high molecular weight hyaluronic acid preparation, from bacterial cells, which makes it safe for patients suffering from avian allergies such as to birds, eggs and/or feathers. Orthovisc® is available as a three or four dose injection.

SUPARTZ®

Supatrz® is a sterile mixture containing purified sodium hyaluronate, from chicken combs. In animal models, Supartz® increased the integrity of the cartilage, reduced the cell death rate and improved the overall joint morphology. It also reduced synovitis, stimulated the production of endogenous HA and penetrated to the damaged cartilage promoting repair. In a large-animal model Supartz® significantly increased the production of endogenous hyaluronic acid in synovial tissue. Finally it has also been proven to reduce levels of pro-inflammatory cytokines and the production of cartilage-degrading enzymes in cultured cells.

Reported side effects include pain, oedema, erythema, warmth or bruising at the site, and headache, temperature and tingling skin. Seriousallergic reaction to SUPARTZ® has been described but is rare.

EUFLEXXA™

Euflexxa™ is a prescription-only injection therapy administered in a course of 3 injections, usually as one injection a week for three weeks, although some authors recommend 5 injections. Pain relief for six months is described.

The most common side effects include pain at the injection site, skin irritation, swelling, and tenderness around the joint. Other side effects include back pain, mild bruising, erythema at the injection site, mild stiffness, increased temperature and muscle pain.

Conclusion:

Viscosupplementation therapy with HA can be safe and effective in the management of osteoarthritis that does not respond to conventional therapies. HA is mainly recommended when NSAIDS are contraindicated, not tolerated or ineffective^{(14), (15)}.

The treatment significantly reduces pain within the first three months and the effect can last for approximately 12 to 18 months.

For small joints (MCPJ, PIPJ, DIPJ) there is a definite advantage in using preparations available in smaller syringes. This can reduce costs and waste given the remarkably small dose accommodated in a small joint space.

References:

1 Zhang, Y. & Jordan, JM. (2010). Epidemiology of osteoarthritis. Clin Geriatr Med, Aug, Vol.26, No.3, pp. 355-369

2 Tang T, Muneta T, Ju Y-J, et al. Serum keratin sulfate transiently increases in the early stage of osteoarthritis during strenuous running of rats: protective effect of intraarticular hyaluronan injection. Arthritis Res Ther. 2008;10:R13. DOI:10.1186/ar2363.

3 Guarda-Nardini, L., Ferronato, G., Favero, L. & Manfredini, D.(2011). Predictive factors of hyaluronic acid injections short-term effectiveness for TMJ degenerative joint disease. J Oral Rehabil, Vol.38, No.5, pp. 315-320

4 Takahashi K, Hashimoto S, Kubo T, et al. Effect of hyaluronan on chondrocyte apoptosis and nitric oxide production in experimentally induced osteoarthritis. J Rheumatol. 2000;27(7):1713-1720.

5 O'Regan, M., Martini, I., Crescenzi, F., De Luca, C. & Lansing, M. (1994). Molecular mechanisms and genetics of hyaluronan biosynthesis. Int J Biol Macromol, Vol.16, No.6, pp. 283-286

6 Asari A, Miyauchi S, Matsuzaka S, et al. Molecular weight-dependent effects of hyaluronate on the arthritic synovium. Arch Histol Cytol. 1998;61(2):125-135.

7 Fukuda K, Hidekazu D, Masafumi T, et al. Hyaluronic acid increases proteoglycan synthesis in bovine articular cartilage in the presence of interleukin-1. J Pharm Exp Ther. 1996;277(3):1672-1675.

8 Mitsui Y, Gotoh M, Nakama K, et al. Hyaluronic acid inhibits mRNA expression of proinflammatory cytokines and cyclooxygenase-2/prostaglandin E₂ production via CD44 in interleukin-1-stimulated subacromial synovial fibroblasts from patients with rotator cuff disease. J Orthop Res. 2008;26:1032-1037.

9 Wang C-T, Lin Y-T, Chiang B-L, Lin Y-H, Hou S-M. High molecular weight hyaluronic acid down-regulates the gene expression of osteoarthritis-associated cytokines and enzymes in fibroblast-like synoviocytes from patients with early osteoarthritis. Osteoarthr Cartilage. 2006;14:1237-1247.

10 Waddell DD, Kolomytkin OV, Dunn S, Marino AA. Hyaluronan suppresses IL-1β-induced metalloproteinase activity from synovial tissue. Clin Orthop Relat Res. 2007;465:241-248.

11 Julovi SM, Yasuda T, Shimizu M, Hiramitsu T, Nakamura T. Inhibition of interleukin-1β-stimulated production of matrix metalloproteinases by hyaluronan via CD44 in human articular cartilage. Arthritis Rheum. 2004;50(2):516-525.

12 Julovi, SM., Ito, H., Nishitani, K., Jackson, CJ. & Nakamura, T. (2011). Hyaluronan inhibits matrix metalloproteinase-13 in human arthritic chondrocytes via CD44 and P38. J Orthop Res, Vol.29, No.2, pp. 258-264

13 A., Giovannangeli, F., Granata, M. & Lagana?, B. (2010). Hylan g-f 20: review of its safety and efficacy in the management of joint pain in osteoarthritis. Clin Med Insights Arthritis Musculoskelet Disord, Vol.20, No.3, pp. 55-68

14 Stahl S, Karsh-Zafrir I, Ratzon N, Rosenberg N. Comparison of intraarticular injection of depot corticosteroid and hyaluronic acid for treatment of degenerative degenerative trapeziometacarpal joints. J Clin Rheumatol 2005;11:299-302.trapeziometacarpal joints. J Clin Rheumatol 2005;11:299-302

Hyaluronic Acid Injection in the Treatment of Small Joint Arthritis in the Hand

Wed, 18 Feb 2015 00:00:00 GMT

Article submitted by: Mr Antonios Mitsakos, SpR in Plastics and Hand Surgery, Chelsea and Westminster Hospital & Mr Maxim Horwitz, Consultant Hand Surgeon, Chelsea and Westminster Hospital

No conflict declared.

Beneficial effects of HA include^{(8),(9),(10),(11),(12)}:

-Inhibition of the lymphocyte transformation that promotes phagocytic activity of macrophages and leukocytes.

-Reduction of adenosine triphosphate and matrix metalloproteinase levels, thereby slowing joint destruction.

-Promotion of prostaglandin release and the normalisation of native HA synthesis⁽¹³⁾

-Acceleration of proteoglycan synthesis by chondrocytes and tissue inhibitor MMP-1 and the collection of free radicals.

-Modification of the structure of cartilage with effects on chondrocytes and cartilage explants, interleukin 1 and oxygen-derived free radicals.

Injection Technique

The intra–articular injection of HA must be performed in a clean environment to minimize the risk of infection.

The following products can be used for the injection of the small joints of the hand. Note that the volume needed for a joint is usually no more than 1ml.

GO-ON®

Hyalgan®

The preparation has not been found to interfere with any other medication for osteoarthritis or any other medical condition. It has also been proven safe for repeat treatment if needed.

SYNVISC®

Synvisc® comes in two different formulations, SYNVISC® and SYNVISC-One®. SYNVISC-One® is a single dose treatment, compared with the three injections required with SYNVISC.

ORTHOVISC®

SUPARTZ®

EUFLEXXA™

Conclusion:

The treatment significantly reduces pain within the first three months and the effect can last for approximately 12 to 18 months.

References:

1 Zhang, Y. & Jordan, JM. (2010). Epidemiology of osteoarthritis. Clin Geriatr Med, Aug, Vol.26, No.3, pp. 355-369

4 Takahashi K, Hashimoto S, Kubo T, et al. Effect of hyaluronan on chondrocyte apoptosis and nitric oxide production in experimentally induced osteoarthritis. J Rheumatol. 2000;27(7):1713-1720.

5 O'Regan, M., Martini, I., Crescenzi, F., De Luca, C. & Lansing, M. (1994). Molecular mechanisms and genetics of hyaluronan biosynthesis. Int J Biol Macromol, Vol.16, No.6, pp. 283-286

6 Asari A, Miyauchi S, Matsuzaka S, et al. Molecular weight-dependent effects of hyaluronate on the arthritic synovium. Arch Histol Cytol. 1998;61(2):125-135.

7 Fukuda K, Hidekazu D, Masafumi T, et al. Hyaluronic acid increases proteoglycan synthesis in bovine articular cartilage in the presence of interleukin-1. J Pharm Exp Ther. 1996;277(3):1672-1675.

10 Waddell DD, Kolomytkin OV, Dunn S, Marino AA. Hyaluronan suppresses IL-1β-induced metalloproteinase activity from synovial tissue. Clin Orthop Relat Res. 2007;465:241-248.

Hyaluronic Acid Injection in the Treatment of Small Joint Arthritis in the Hand

Wed, 18 Feb 2015 00:00:00 GMT

Article submited by Mr Antonios Mitsakos, SpR in Plastics and Hand Surgery, Chelsea and Westminster Hospital & Mr Maxim Horwitz, Consultant Hand Surgeon, Chelsea and Westminster Hospital

No conflict declared.

Beneficial effects of HA include^{(8),(9),(10),(11),(12)}:

-Inhibition of the lymphocyte transformation that promotes phagocytic activity of macrophages and leukocytes.

-Reduction of adenosine triphosphate and matrix metalloproteinase levels, thereby slowing joint destruction.

-Promotion of prostaglandin release and the normalisation of native HA synthesis⁽¹³⁾

-Acceleration of proteoglycan synthesis by chondrocytes and tissue inhibitor MMP-1 and the collection of free radicals.

-Modification of the structure of cartilage with effects on chondrocytes and cartilage explants, interleukin 1 and oxygen-derived free radicals.

Injection Technique

The intra–articular injection of HA must be performed in a clean environment to minimize the risk of infection.

The following products can be used for the injection of the small joints of the hand. Note that the volume needed for a joint is usually no more than 1ml.

GO-ON®

Hyalgan®

The preparation has not been found to interfere with any other medication for osteoarthritis or any other medical condition. It has also been proven safe for repeat treatment if needed.

SYNVISC®

Synvisc® comes in two different formulations, SYNVISC® and SYNVISC-One®. SYNVISC-One® is a single dose treatment, compared with the three injections required with SYNVISC.

ORTHOVISC®

SUPARTZ®

EUFLEXXA™

Conclusion:

The treatment significantly reduces pain within the first three months and the effect can last for approximately 12 to 18 months.

References:

1 Zhang, Y. & Jordan, JM. (2010). Epidemiology of osteoarthritis. Clin Geriatr Med, Aug, Vol.26, No.3, pp. 355-369

4 Takahashi K, Hashimoto S, Kubo T, et al. Effect of hyaluronan on chondrocyte apoptosis and nitric oxide production in experimentally induced osteoarthritis. J Rheumatol. 2000;27(7):1713-1720.

5 O'Regan, M., Martini, I., Crescenzi, F., De Luca, C. & Lansing, M. (1994). Molecular mechanisms and genetics of hyaluronan biosynthesis. Int J Biol Macromol, Vol.16, No.6, pp. 283-286

6 Asari A, Miyauchi S, Matsuzaka S, et al. Molecular weight-dependent effects of hyaluronate on the arthritic synovium. Arch Histol Cytol. 1998;61(2):125-135.

7 Fukuda K, Hidekazu D, Masafumi T, et al. Hyaluronic acid increases proteoglycan synthesis in bovine articular cartilage in the presence of interleukin-1. J Pharm Exp Ther. 1996;277(3):1672-1675.

10 Waddell DD, Kolomytkin OV, Dunn S, Marino AA. Hyaluronan suppresses IL-1β-induced metalloproteinase activity from synovial tissue. Clin Orthop Relat Res. 2007;465:241-248.

Hyaluronic Acid Injection in the Treatment of Small Joint Arthritis in the Hand

Wed, 18 Feb 2015 00:00:00 GMT

Article submitted by: Mr Antonios Mitsakos, SpR in Plastics and Hand Surgery, Chelsea and Westminster Hospital & Mr Maxim Horwitz, Consultant Hand Surgeon, Chelsea and Westminster Hospital

No conflict declared.

Beneficial effects of HA include^{(8),(9),(10),(11),(12)}:

-Inhibition of the lymphocyte transformation that promotes phagocytic activity of macrophages and leukocytes.

-Reduction of adenosine triphosphate and matrix metalloproteinase levels, thereby slowing joint destruction.

-Promotion of prostaglandin release and the normalisation of native HA synthesis⁽¹³⁾

-Acceleration of proteoglycan synthesis by chondrocytes and tissue inhibitor MMP-1 and the collection of free radicals.

-Modification of the structure of cartilage with effects on chondrocytes and cartilage explants, interleukin 1 and oxygen-derived free radicals.

Injection Technique

The intra–articular injection of HA must be performed in a clean environment to minimize the risk of infection.

The following products can be used for the injection of the small joints of the hand. Note that the volume needed for a joint is usually no more than 1ml.

GO-ON®

Hyalgan®

The preparation has not been found to interfere with any other medication for osteoarthritis or any other medical condition. It has also been proven safe for repeat treatment if needed.

SYNVISC®

Synvisc® comes in two different formulations, SYNVISC® and SYNVISC-One®. SYNVISC-One® is a single dose treatment, compared with the three injections required with SYNVISC.

ORTHOVISC®

SUPARTZ®

EUFLEXXA™

Conclusion:

The treatment significantly reduces pain within the first three months and the effect can last for approximately 12 to 18 months.

References:

1 Zhang, Y. & Jordan, JM. (2010). Epidemiology of osteoarthritis. Clin Geriatr Med, Aug, Vol.26, No.3, pp. 355-369

4 Takahashi K, Hashimoto S, Kubo T, et al. Effect of hyaluronan on chondrocyte apoptosis and nitric oxide production in experimentally induced osteoarthritis. J Rheumatol. 2000;27(7):1713-1720.

5 O'Regan, M., Martini, I., Crescenzi, F., De Luca, C. & Lansing, M. (1994). Molecular mechanisms and genetics of hyaluronan biosynthesis. Int J Biol Macromol, Vol.16, No.6, pp. 283-286

6 Asari A, Miyauchi S, Matsuzaka S, et al. Molecular weight-dependent effects of hyaluronate on the arthritic synovium. Arch Histol Cytol. 1998;61(2):125-135.

7 Fukuda K, Hidekazu D, Masafumi T, et al. Hyaluronic acid increases proteoglycan synthesis in bovine articular cartilage in the presence of interleukin-1. J Pharm Exp Ther. 1996;277(3):1672-1675.

10 Waddell DD, Kolomytkin OV, Dunn S, Marino AA. Hyaluronan suppresses IL-1β-induced metalloproteinase activity from synovial tissue. Clin Orthop Relat Res. 2007;465:241-248.

Hyaluronic Acid Injection in the Treatment of Small Joint Arthritis in the Hand

Wed, 18 Feb 2015 00:00:00 GMT

Article submitted by Mr Antonios Mitsakos, SpR in Plastics and Hand Surgery, Chelsea and Westminster Hospital & Mr Maxim Horwitz, Consultant Hand Surgeon, Chelsea and Westminster Hospital

No conflict declared.

Beneficial effects of HA include^{(8),(9),(10),(11),(12)}:

-Inhibition of the lymphocyte transformation that promotes phagocytic activity of macrophages and leukocytes.

-Reduction of adenosine triphosphate and matrix metalloproteinase levels, thereby slowing joint destruction.

-Promotion of prostaglandin release and the normalisation of native HA synthesis⁽¹³⁾

-Acceleration of proteoglycan synthesis by chondrocytes and tissue inhibitor MMP-1 and the collection of free radicals.

-Modification of the structure of cartilage with effects on chondrocytes and cartilage explants, interleukin 1 and oxygen-derived free radicals.

Injection Technique

The intra–articular injection of HA must be performed in a clean environment to minimize the risk of infection.

The following products can be used for the injection of the small joints of the hand. Note that the volume needed for a joint is usually no more than 1ml.

GO-ON®

Hyalgan®

The preparation has not been found to interfere with any other medication for osteoarthritis or any other medical condition. It has also been proven safe for repeat treatment if needed.

SYNVISC®

Synvisc® comes in two different formulations, SYNVISC® and SYNVISC-One®. SYNVISC-One® is a single dose treatment, compared with the three injections required with SYNVISC.

ORTHOVISC®

SUPARTZ®

EUFLEXXA™

Conclusion:

The treatment significantly reduces pain within the first three months and the effect can last for approximately 12 to 18 months.

References:

1 Zhang, Y. & Jordan, JM. (2010). Epidemiology of osteoarthritis. Clin Geriatr Med, Aug, Vol.26, No.3, pp. 355-369

4 Takahashi K, Hashimoto S, Kubo T, et al. Effect of hyaluronan on chondrocyte apoptosis and nitric oxide production in experimentally induced osteoarthritis. J Rheumatol. 2000;27(7):1713-1720.

5 O'Regan, M., Martini, I., Crescenzi, F., De Luca, C. & Lansing, M. (1994). Molecular mechanisms and genetics of hyaluronan biosynthesis. Int J Biol Macromol, Vol.16, No.6, pp. 283-286

6 Asari A, Miyauchi S, Matsuzaka S, et al. Molecular weight-dependent effects of hyaluronate on the arthritic synovium. Arch Histol Cytol. 1998;61(2):125-135.

7 Fukuda K, Hidekazu D, Masafumi T, et al. Hyaluronic acid increases proteoglycan synthesis in bovine articular cartilage in the presence of interleukin-1. J Pharm Exp Ther. 1996;277(3):1672-1675.

10 Waddell DD, Kolomytkin OV, Dunn S, Marino AA. Hyaluronan suppresses IL-1β-induced metalloproteinase activity from synovial tissue. Clin Orthop Relat Res. 2007;465:241-248.

Hyaluronic Acid Injection in the Treatment of Small Joint Arthritis in the Hand

Wed, 18 Feb 2015 00:00:00 GMT

Article submitted by Mr Antonios Mitsakos, SpR in Plastics and Hand Surgery, Chelsea and Westminster Hospital & Mr Maxim Horwitz, Consultant Hand Surgeon, Chelsea and Westminster Hospital

No conflict declared.

Beneficial effects of HA include^{(8),(9),(10),(11),(12)}:

-Inhibition of the lymphocyte transformation that promotes phagocytic activity of macrophages and leukocytes.

-Reduction of adenosine triphosphate and matrix metalloproteinase levels, thereby slowing joint destruction.

-Promotion of prostaglandin release and the normalisation of native HA synthesis⁽¹³⁾

-Acceleration of proteoglycan synthesis by chondrocytes and tissue inhibitor MMP-1 and the collection of free radicals.

-Modification of the structure of cartilage with effects on chondrocytes and cartilage explants, interleukin 1 and oxygen-derived free radicals.

Injection Technique

The intra–articular injection of HA must be performed in a clean environment to minimize the risk of infection.

The following products can be used for the injection of the small joints of the hand. Note that the volume needed for a joint is usually no more than 1ml.

GO-ON®

Hyalgan®

The preparation has not been found to interfere with any other medication for osteoarthritis or any other medical condition. It has also been proven safe for repeat treatment if needed.

SYNVISC®

Synvisc® comes in two different formulations, SYNVISC® and SYNVISC-One®. SYNVISC-One® is a single dose treatment, compared with the three injections required with SYNVISC.

ORTHOVISC®

SUPARTZ®

EUFLEXXA™

Conclusion:

The treatment significantly reduces pain within the first three months and the effect can last for approximately 12 to 18 months.

References:

1 Zhang, Y. & Jordan, JM. (2010). Epidemiology of osteoarthritis. Clin Geriatr Med, Aug, Vol.26, No.3, pp. 355-369

4 Takahashi K, Hashimoto S, Kubo T, et al. Effect of hyaluronan on chondrocyte apoptosis and nitric oxide production in experimentally induced osteoarthritis. J Rheumatol. 2000;27(7):1713-1720.

5 O'Regan, M., Martini, I., Crescenzi, F., De Luca, C. & Lansing, M. (1994). Molecular mechanisms and genetics of hyaluronan biosynthesis. Int J Biol Macromol, Vol.16, No.6, pp. 283-286

6 Asari A, Miyauchi S, Matsuzaka S, et al. Molecular weight-dependent effects of hyaluronate on the arthritic synovium. Arch Histol Cytol. 1998;61(2):125-135.

7 Fukuda K, Hidekazu D, Masafumi T, et al. Hyaluronic acid increases proteoglycan synthesis in bovine articular cartilage in the presence of interleukin-1. J Pharm Exp Ther. 1996;277(3):1672-1675.

10 Waddell DD, Kolomytkin OV, Dunn S, Marino AA. Hyaluronan suppresses IL-1β-induced metalloproteinase activity from synovial tissue. Clin Orthop Relat Res. 2007;465:241-248.

Medtronic CoreValve safer than surgery in bypass patients: study

Thu, 29 Jan 2015 00:00:00 GMT

Cordis Launches Saber PTA Dilatation Balloon for Peripheral Arterial Disease

Sun, 12 Oct 2014 00:00:00 GMT

Diagnostic & Interventional Radiology reports that Cordis Corp. announced the launch of its Saber PTA (percutaneous transluminal angioplasty) dilatation catheter for the treatment of patients with peripheral arterial disease (PAD). The Saber catheter is cleared for use and now available in Europe, the United States and Japan. This new product offers crossability and a comprehensive offering of balloon sizes on the widely used 0.018-inch over-the-wire (OTW) platform.

Developed to complement the Cordis PTA portfolio as a next-generation, high-performance workhorse 0.018-inch PTA balloon catheter, Saber is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Read the full article here.

Cook Launches High Flow Cantata Microcatheter

Sun, 12 Oct 2014 00:00:00 GMT

Cxvascular.com reports that Cook Medical's Cantata microcatheter is now available in a 2.9F size with a high-flow 0.027” ID that allows the delivery of a wider range of embolic agents. It complements the existing line of superselective microcatheters (0.021” ID and 0.025” ID), the Cantata 2.9 is hand-shapeable and has a full-length braid for optimal torqueability.

Read the full article here.

Abbott Announces FDA Approval of its Supera Stent to Treat People with Peripheral Artery Disease

Tue, 29 Apr 2014 00:00:00 GMT

Read Abbott Vascular's press release here.

Doc Technique Plays Major Part in TKA Failures

Sun, 09 Mar 2014 00:00:00 GMT

Medpagetoday reports that as opposed to 15 years ago, implant performance is no longer the primary reason for failure. In over 70% of cases where the cause was aseptic loosening, infection, or instability, the mechanisms were at least in part under the surgeon's control.

A 'Handheld Laboratory' Offers the Potential to Diagnose Malaria in Under 15 Minutes

Sat, 22 Feb 2014 00:00:00 GMT

Medcitynews.com reports on what is described as a 'handheld laboratory' which is designed to diagnose malaria in under 15 minutes. It could be in the hands of healthcare workers overseas within 2 years if the manufacturer, QuantuMDx can meet its goals.

The medical device company has turned to Indiegogo in search of $50,000 for field trials of miniaturized DNA sequencing device.They say that unlike many other crowdfunding campaigns, this is no early-stage project and that donors will be directly contributing to the development and testing of the device.

How the device works is that a finger-prick blood sample is placed on one of QuantuMDx’s disease-specific cartridges which is placed in the device. Within 15 minutes results appear on the touch screen, telling the healthcare worker whether malaria was detected in the sample, what species it is and whether it showed traits of drug resistance.

Read the full article here.

Early IMPROVE Trial Results for Ruptured Aortic Aneurysm

Sun, 16 Feb 2014 00:00:00 GMT

Early results have been published for the IMPROVE trial which is for patients with ruptured abdominal aortic aneurysm. It is designed to test the hypothesis that a policy of endovascular repair, whenever possible, saves lives in comparison to the standard treatment of open surgical repair. The trial is supported by the NIHR Health Technology Assessment programme.

The trial recruited 600 patients over a 27 month period, to provide 90% power to detect (as significant at 5%) a difference in 30-day mortality of 14%, with mortality estimated at 44.6% in the open repair group and 30.4% in the EVAR first strategy group.

Key findings so far are:

The proportion of patients leaving hospital alive was almost the same in the endovascular repair (EVAR) group (64%) and in the open repair group (62%).

EVAR appeared to be more beneficial in women than men.

Patients in the EVAR group were discharged from hospital sooner and nearly always directly to home, compared with the open repair group where about a quarter of patients needed a period of convalescent care.

Patients operated on outside routine working hours had worse outcomes compared to those treated during routine working hours.

Patients who received EVAR under local anaesthesia did much better than those who received EVAR under general anaesthesia.

The average costs were similar between the EVAR and open repair groups but the NHS will need to know more about longer-term costs for both treatments.

Trial Shows that Stents are of No Help in Renal Artery Stenosis

Sun, 16 Feb 2014 00:00:00 GMT

Medpage Today reports that findings from the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial confirmed that stenting with aggressive hypertension and lipid lowering drug treatment was no better than drug treatment alone for preventing death from cardiovascular or renal causes or preventing complications such as heart attack, stroke, or progression of renal failure.

The trial results were published online in the New England Journal of Medicine and reported simultaneously at the American Heart Association meeting.

Read MedPage Today's article here.

Catheter Withdrawn From the Market Following Trial Findings

Sun, 16 Feb 2014 00:00:00 GMT

Endovascular Today reports that Medtronic has recalled its Amphirion Deep Balloon Dilation Catheter following the latest trial results for the device.

They say that in a notification sent to customers in early November, Medtronic stated that after 12 months of follow-up in the IN.PACT DEEP study, there was no difference found between the In.Pact Amphirion DEB treatment group and the standard balloon angioplasty control group in any of the study's three primary outcome measures.

The study also identified a potential safety signal with a trend toward an increased rate of major amputations in the DEB study arm.

Read the full article here.

Doctor (and Which Medical Device Editor-in-Chief) Creates New Pelvis Using a 3D Printer

Tue, 11 Feb 2014 00:00:00 GMT

The Daily Telegraph (UK) reports that a patient who lost half his pelvis to bone cancer has had a replacement which was created by a 3D printer.

Craig Gerrand, a consultant orthopaedic surgeon (who is also an Editor-in-Chief for whichmedicaldevice.com) and the team from the North of England Bone and Soft Tissue Tumour Service at Freeman Hospital carried out this novel reconstruction on an unnamed man in his 60s three years ago. This device won Which Medical Device Device of the Year in 2011, but has just been reported by the national press as part of a discussion about innovation in surgery.

The patient, who had half his pelvis removed because of a rare cancer called chondrosarcoma, is now walking again with the aid of a stick. Craig said that so much bone had to be removed to stop the spread of cancer, a standard implant would not have been feasible.

The First Leadless Pacemaker is Implanted in the UK

Mon, 27 Jan 2014 00:00:00 GMT

St. Jude Medical has released a pres release announcing the UK’s first installation of a leadless pacemaker, the Nanostim, was carried out by Professor Richard Schilling at St Bartholomew’s Hospital, London, UK.

They say that the Nanostim leadless pacemaker is less than 10% the size of a conventional pacemaker and smaller than a triple-A battery. The minimally invasive procedure took only eight minutes compared to invasive conventional pacemaker surgery. Nanostim is positioned through the femoral artery and therefore eliminates the need for large surgical incisions (meaning less risk of infection) and eliminates the visible lump and scar at a conventional pacemaker’s implant site.

The procedure also provides less risk to the patient and quicker recovery.

Read the full press release from St Jude Medical here.

Biotronik Launches Passeo-18 Lux Drug-Releasing Balloon in Europe

Wed, 22 Jan 2014 00:00:00 GMT

Biotronik announced the release of its Passeo-18 Lux drug-releasing balloon (DRB) in all countries recognizing CE Mark. The device recently earned European CE Mark approval.

The company stated that the Passeo-18 Lux is a novel combination device for treating de novo and restenotic femoropopliteal lesions. The device’s design is based on the company’s Passeo-18 percutaneous transluminal angioplasty (PTA) catheter, which is coated with a matrix of antiproliferative paclitaxel and a biocompatible excipient that enables an optimal drug transfer to the target lesion tissue. The Passeo-18 Lux includes a novel protective insertion aid to facilitate easier device introduction and handling.

Read the full article here.

Mixed Results for Metal Ions Test in Metal-on-Metal Hips

Sun, 19 Jan 2014 00:00:00 GMT

An interesting article featured last year on MedPage Today which discusses the validity of measuring metal ion levels in whole blood in patients with metal-on-metal hip implants.

Read the full article here.

Renal Denervation, HTN-3 Fails to Reach its Primary Efficacy Endpoint

Fri, 10 Jan 2014 00:00:00 GMT

The trial has met its primary safety endpoint and no specific action is required for patients who have been treated.

Medtronic intends to:

1. Suspend enrollment in SYMPLICITY HTN-4 US, HTN Japan and HTN India.

2. Inform trial sites, investigators, customers and regulatory bodies of the findings.

3. Continue to ensure access to the Symplicity system at the discretion of physicians where it is regulatory approved.

4. Continue with the post market surveillance registry.

FULL PRESS RELEASE

CE Mark Approval for AngioVac

Thu, 31 Oct 2013 00:00:00 GMT

Cardiovasculardevices.com reports that CE Mark approval had been granted to AngioDynamics for the AngioVac venous drainage cannula and cardiopulmonary bypass circuit.

Read the full article here.

MitraClip Gains FDA Approval

Thu, 31 Oct 2013 00:00:00 GMT

The device will be launched immediately in the US.

Read Abbott Vascular's press release here.

Google Glass: Finding true clinical value

Thu, 31 Oct 2013 00:00:00 GMT

Editorial describing the potential of Google Glass in Interventional Radiology by Dr Phil Haslam and Dr Sebastian Mafeld.

CE Approval for Boston Scientific Heart Valve Implant

Tue, 29 Oct 2013 00:00:00 GMT

Mass Device reports that Boston Scientific has announced that its Lotus transcatheter heart valve implant has been awarded CE approval. The manufacturer immediatley made the device available to the European marketplace.

According to Boston Sicntific, the Lotus valve is the only aortic valve device that allows physicians to assess its final position before release. They say that it is designed to minimise the aortic regurgitation.

Source: Mass Device, 28 October 28 2013.

Read the full article here.

St. Jude Medical Reports Positive Results In Portico Transfemoral CE Trial

Tue, 29 Oct 2013 00:00:00 GMT

St. Jude Medical has announced the positive results for the 23 and 25 mm Portico Transcatheter Aortic Heart Valves in the Portico Transfemoral CE Mark Trial or Portico TF CE Trial. They said that the patients enrolled in the study experienced a significant improvement in valve function at 30 days.

Source: RTTNews.com

Read the full article here.

Anaconda Voluntary Recall

Tue, 22 Oct 2013 00:00:00 GMT

We have just heard that there is a voluntary recall of the Vascutek Anaconda infra renal aortic stent graft. There have apparently been 3 cases (out of approx 17,000) where the release wire has snapped during deployment preventing the graft from being detached from the delivery system.

National Joint Registry Publishes 10th Annual Report

Mon, 07 Oct 2013 00:00:00 GMT

The National Joint Registry (NJR) for England and Wales has published its 10th Annual Report. It now includes data from more than 1.4 million operations – more growth is expected now Northern Ireland has joined and the Registry includes elbow and shoulder replacement.

Highlights of this year’s report include:

First analysis of English Patient Reported Outcomes Measures (PROMs)

First nine months of elbow replacement and shoulder replacement data

Second complete year of ankle replacement data

Highest-ever patient consent rates (91%)

In-depth study: Metal-on-metal resurfacing

Trust-, Local Health Board- and unit-level activity and outcomes data for hip and knee procedures

The report is available here.

Device of the Year 2013 T&Cs

Tue, 01 Oct 2013 00:00:00 GMT

OFFICIAL RULES for ‘Which Medical Device – Device of the Year 2013 - submitting a nomination’

By participating in the nominations, entrants agree to be bound by these Official Rules and by the decisions of the Which Medical Device judging panel, which are final in all matters relating to this competition.

No purchase or payment of any kind is necessary to win. A purchase will not improve your chances of winning.

ELIGIBILITY: The competition is open to all those who complete the nomination form and are at least 18 years of age. Void where prohibited or restricted by law. All employees of Which Medical Device and their immediate families (spouse, parent, sibling or child or their respective spouses) or those residing in the same households of employees, whether related or not, are not eligible to enter or to win. The competition is subject to all applicable laws.

TIMING: The survey will start 12 November 2013 and will end 31st January 2014 (the “Nomination Period”).

HOW TO NOMINATE: Nomination forms completed as instructed during the Entry Period will have the reason for nominating a medical device considered by the Which Medical Device judging panel. Limit to one (1) entry per device, per person. After the first nomination submission for a particular device, additional nomination submissions for the same device will not result in additional entries.

NO PRIZES WILL BE ISSUED TO NOMINATORS WITH THE EXCEPTION OF A KINDLE FIRE HD WHICH WILL BE ISSUED TO THE NOMINATOR OF WHAT THE JUDGING PANEL DEEMS TO BE THE 'BEST REASON FOR NOMINATING'. The winner's name can be obtained by contacting Which Medical Device after 31 January 2014. No cash alternative will be offered. Which Medical Device reserves the right to replace the Kindle Fire HD with a different device should this exact one not be available for any reason.

AWARDS: The judges decision may not be questioned and is final.

DRAW AND AWARDING OF PRIZES: Judging will take place within fifteen (15) days after the end of the Nomination Period. Nominators of the winning devices will be notified via email within ten (10) days of the date of the closing date draw. Non-winning devices will not "roll-over" into awards held in the future by the Which Medical Device. Nominators of the wining devices may be required to execute and return an affidavit of eligibility, a liability release and, where legal, a publicity release within fourteen (14) days of notification.

GENERAL CONDITIONS: Entry constitutes permission for Which Medical Device and its designees to use each winning device nominator's name and location and/or likeness for advertising, promotional, and other purposes in any and all media now or hereafter known throughout the world in perpetuity, without further compensation, notification and permission, except where prohibited by law, and the nominator of winning devices agrees to confirm such permission in writing promptly upon request. IN NO EVENT WILL THE SPONSOR, ITS RESPECTIVE PARENTS, AFFILIATES, SUBSIDIARIES, ADVERTISING AND PROMOTION AGENCIES, DEALERS, DISTRIBUTORS, SUPPLIERS, OFFICERS, EMPLOYEES, REPRESENTATIVES AND AGENTS BE RESPONSIBLE OR LIABLE FOR ANY DAMAGES OR LOSSES OF ANY KIND (INCLUDING WITHOUT LIMITATION, DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES) ARISING OUT OF PARTICIPATION IN THE AWARDS. Any and all disputes, claims and causes of action arising out of or connected with this awards scheme shall be resolved individually, without resort to any form of class action, and exclusively by arbitration. Any and all claims, judgments and awards shall be limited to actual out-of pocket costs incurred, including costs associated with making a nomination to thie awards scheme but in no event legal fees. If for any reason the awards scheme is not capable of running as planned, including for reasons of tampering, unauthorised intervention, fraud or other causes which corrupt or affect the administration, security, fairness, integrity or proper conduct of the scheme, Which Medical Device reserves the right at its sole discretion to cancel, terminate, modify and/or suspend the scheme and to disqualify any individual who tampers with the nomination process, violates these Official Rules, or acts in a disruptive manner.

LIABILITY: Which Medical Device and its respective subsidiaries, affiliates and advertising, promotion and production agencies, and their respective officers, directors, employees, representatives and agents are not responsible for lost, late, incorrect, incomplete, stolen, garbled, misdirected, undelivered or delayed nominations or for nominations not received by the specified deadline; or for printing, distribution, production, technical, human or other errors relating to or in connection with the scheme, including, without limitation, errors in any advertising materials, the administration of the scheme, the processing of nominations or the announcement of the winning devices.

WINNERS LIST: Details of the winning devices will be published on www.whichmedicaldevice.com

USE OF DATA: Entries and the information contained therein will be used by Which Medical Device in accordance with its privacy policy, available at http://www.whichmedicaldevice.com/privacy-policy/.

By nominating a device and providing your e-mail address, entrants hereby agree to Which Medical Device’s collection and usage of their personal information and acknowledge that they have read and accepted Which Medical Device’s privacy policy.

JURISDICTION: WMD Device of the Year 2013 and these Official Rules shall be governed by and construed in accordance with the laws of England, UK.

Smart Spoon Enables Tremor Patients to Dine with Dignity

Mon, 23 Sep 2013 00:00:00 GMT

MedGadget reports on a range of new products from San Fransisco based Lift Labs that includes patented spoon technology to stabilise tremors of the hands. According to the manufacturer's website, the spoon is kept steady using an 'innovative Active Cancellation of Tremor technology'. You can read further articles about the high tech spoon here.

Essential TremorsLift Labs is developing an iOS and Android app called Lift Pulse that measures tremor frequency and amplitude using the sensors within smartphones. Patients with Parkinson’s disease can track their tremors using the app and can also compare their tremors to preset baselines. The app is available for free on iTunes and Android markets.

Lift Labs has also developed an app to help Parkinson’s patients to walk called Lift Stride. The app allows patients to adjust the setting to just above their walking speed. They say that app is works best with a Bluetooth headset.

Click here to see more details on Lift Lab's website.

Source: MedGadget

Total Knee Replacement - A guide to good clinical practice

Wed, 04 Sep 2013 00:00:00 GMT

From New Zealand Orthopaedic Association. A guide covering practice from outpatient consultation to follow up.

CE Mark Granted for Next Generation of EnligHTN

Fri, 30 Aug 2013 00:00:00 GMT

A press release from device manufacturer St Jude Medical has announced CE mark approval on the company's next generation EnligHTN Renal Denervation System. The system which is designed for treating patients with drug-resistant, uncontrolled hypertension, cuts total ablation time by over 80% in comparison to the first generation system from approximately 24 minutes to just four minutes. The EnligHTN system will be on display during the 2013 European Society of Cardiology (ESC) meeting from August 31 to September 03 (2013).

“The new EnligHTN system improves the procedure by significantly reducing ablation time and providing optimized ablation monitoring feedback,” said Thomas Lüscher, professor and chairman of Cardiology, at the Cardiovascular Center at the University Hospital in Zurich and editor in chief of the European Heart Journal.

They say that St Jude Medical is conducting five renal denervation studies including the EnligHTNment landmark trial. This study is the first large-scale trial that will examine the long-term effects of renal denervation to see if the therapy also reduces the risk of heart attack, stroke, heart failure requiring hospitalization, as well as cardiovascular death in patients with uncontrolled hypertension.

The next-generation EnligHTN system is currently being evaluated in the EnligHTN III study, an international, non-randomized clinical trial that will enroll up to 50 patients in Australia and New Zealand. This study expands on EnligHTN I trial research of the first generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe, rapid and sustained drop in blood pressure. After thirty days, systolic blood pressure was reduced by an average of 28 mmHg (millimeters of mercury) that remained stable with a reduction of 27 mmHg points one year after treatment.

In 2012, the first-generation EnligHTN Renal Denervation System earned European CE Mark approval and was launched in several markets. The EnligHTN systems are not approved for use in the US.

Source: St Jude Medical

New Study Results Immiment for Implantable Heartpump

Wed, 21 Aug 2013 00:00:00 GMT

Mass Device reports that medical device manufacturer HeartWare is progressing a premarket approval application with the FDA. The company anticipates that new study results will address concerns about the rate of neurological events associated with with its Endurance implantable heart pump.

They say that researchers noted an unexpectedly high rate of ischemic and hemorrhagic strokes in HeartWare patients (6.7% and 5.1% respectively) in comparison to a control pump (4.3% and 0%, respectively). Apparently, Heartware subsequently targeted blood pressure management as a potential route for stemming further adverse events.

The manufacturer is working towards presenting the latest clinical findings at the 2014 American Heart Association or the subsequent meeting of the American College of Cardiology.

Source: Mass Device

Read the full article here.

New Port Reduces Occurrence of Blood Clots

Wed, 21 Aug 2013 00:00:00 GMT

Poststar.com reports that the FDA has approved AngioDynamic's BioFlo Port. The device is inserted under the skin of patients where frequent or prolonged access to the cardiovascular system is needed for treatments such as chemotherapy.

They say that the BioFlo Port, similar to AngioDynamic's BioFlo catheter line, has been shown to greatly reduce the occurrence of blood clots. Apparently, the BioFlo Port reduces such clotting by some 96% compared with non-coated conventional port catheters. Anti-thrombus technology is incorporated into the material from which it is manufactured whilst other devices use coatings or drug-eluting materials that show reduced efficacy over time.

AngioDynamics will launch the new ports next year.

Source: Poststar.com

Read the full article here.

The Wall Street Journal also reports on the device.

Cook's Zilver PTX Stent Returns to the Marketplace

Mon, 12 Aug 2013 00:00:00 GMT

Angioplasty.org reports that Cook Medical has resumed distribution of the Zilver PTX drug-eluting stent designed for use in treating peripheral artery disease. The manufacturer has stated that the FDA has approved their revision of the catheter tip separation issue that lead to Cook's voluntary recall in April 2013. This was followed by an FDA Class I recall in May.

The the only drug-eluting stent approved to treat peripheral artery disease, the Zilver PTX is available in the US, Japan, Europe and other markets. Cook say that clinical trials have shown that compared to bare metal stents, the device provides more prolonged results and can reduce repeat procedures by 50%.

Read the full article, which includes a press release from Cook Medical, here.

Source: Anioplasty.org

New Line of Guidewires for Treating Multiple Lesions

Wed, 24 Jul 2013 00:00:00 GMT

Medgadget reports that Biotronic has launched a new line of guidewires. They say that the Galeo Pro line features a stainless steel core that provides device strength and durability when treating multiple lesions using only one guidewire.

A Controlled Transmission Platform technology within the device is designed to privide torque control and steerability during guidewire delivery. The wire has a hydrophilic coating to improve control by letting a clinician feel the frictional forces at the tip rather than along the length of the device.

Read the full article here.

Source: Medgadget

US and Europe Approval Given for Stent Placement Catheter

Tue, 16 Jul 2013 00:00:00 GMT

The Boston Business Journal reports that both US and European approval has been granted for a device designed to assist stent and angioplasty balloon placement.

The Guidezilla Guide Extension Catheter from Boston Scientific is a stainless steel tube with a low friction coating that can reduce the amount of time it takes to insert devices into difficult to reach arteries.

Source: Boston Business Journal

Read the full article here.

FDA Approves Implantable Sensor System for Knee Surgery

Mon, 01 Jul 2013 00:00:00 GMT

Healthtechzone reports that Orthosensor has received FDA approval for its Verasense System. They say that the manufacturer's range of low-cost implantable sensor systems for orthopedic surgeons to provide knee, hip, joint and shoulder replacements for patients, have, so far, provided optimal short and long term clinical outcomes.

The Verasense quantifies joint loading and balance and is compatible for use with multiple knee implant systems. It is designed to be an easy-to-use quality telemetry solution containing embedded sensors and customised circuitry to give clinicians data on alignment and implant positions in a knee replacement procedure. The device is intended to reduce the incidence of misalignment and ligament imbalance for post total knee replacement.

The system provides real-time feedback on soft tissue balance during knee-replacement surgery and quantitative data that clinicians can integrate with their judgment, experience and skill set to help improve patient care and make better evidence-based decisions.

Apparently, the Verasense has been adopted by over 35 orthopedic centers in the US, already.

Source: Healthtechzone

FDA Approves Endovascular Repair Stent

Tue, 25 Jun 2013 00:00:00 GMT

StockMarketWire reports that the the FDA has approved Lombard Medical Technologies' Aorfix Delivery System which is designed for the endovascular repair of abdominal aortic aneurysms. They say that the product is the manufacturer's next generation delivery system for its Aorfix stent graft which was approved by the FDA in February 2013.

Source: StockMarketWire.

Read the original article here.

New Angioplasty Balloon Catheter Primed for Release in the US and Europe

Tue, 18 Jun 2013 00:00:00 GMT

Medgadget reports that medical device manufacturer Medtronic plans to take its new Pacific Plus percutaneous transluminal angioplasty balloon catheter to market in both the US and Europe. This follows the acquisition of both FDA and CE Mark approvals for the device.

The catheter is designed to treat narrowing within renal, iliac, iliofemoral, femoral, popliteal and infrapopliteal arteries. It has a hydrophilic coating and the company promises improved navigation and crossability through the obstruction.

Available in a range of sizes, the Pacific Plus is an over-the-wire peripheral balloon that is compatible with 0.014-inch and 0.018-inch guidewires and 4F or 5F introducer sheaths.

They say that the new device complements Medtronic's existing Pacific Xtreme PTA catheter.

Source: Medgadget, 12 June 2013

Read the full article here.

Bard Begins Lutonix BTK Trial

Mon, 17 Jun 2013 00:00:00 GMT

MHRA Tracking System Aims to Improve on Device Monitoring and Patient Alerts

Mon, 10 Jun 2013 00:00:00 GMT

A press release from the MHRA has announced that four NHS trusts (UK) will pilot a new tracking system which aims to improve on safety information received about high risk medical devices so that patients and healthcare professionals can be alerted more quickly on any potential safety problems. Such devices include breast implants, heart vales and pacemakers.

Unique device identifiers will be added to hospital patients' electronic records and national Hospital Episode Statistics databases. An analysis by the Clinical Practice Research Datalink (CPRD) will then enable the MHRA to better assess the performance of the devices and to trace patients in the event of a device recall or safety alert, without the need for multiple device registries.

This project is one of 11 established by the MHRA to strengthen the regulation of medical devices as part of its response to the review into PIP breast implants by Health Minister Lord Howe, in May 2012. Many of these projects are still in early development because of their complexity but the MHRA reports progress in several key areas.

Source: MHRA Press Release, 07 June 2013

The MHRA’s progress report in response to the review by Lord Howe can be viewed here.

View Lord Howe's May 2012 review here.

Metal Bearing to be Discontinued

Thu, 30 May 2013 00:00:00 GMT

DePuy Orthopaedics, a division of Johnson & Johnson, will stop worldwide sales of its Ultamet Metal-on-Metal Articulation and Complete Ceramic-on-Metal Acetabular Hip Systems on August 31. It will also discontinue the metal lining used in these systems and in its Pinnacle Acetabular Cup System. Versions of the Pinnacle that use plastic and ceramic liners will not be affected.

New MRI Technique Improves Imaging of Soft Tissue & Bone in Patients with Metal Joint Implants

Tue, 28 May 2013 00:00:00 GMT

Medgadget reports that GE Healthcare has introduced a new MRI technique that improves imaging of soft tissue and bone in patients with metal joint implants. They say that MAVRIC SL helps to reduce artifacts caused by the presence of metal in both in-plane and through-plane dimensions in comparison to conventional MR techniques.

Apparently, MAVRIC SL allows for MRI to be used to monitor for adverse reactions in and around the implant area. MAVRIC SL consists of an acquisition technique and post-processing software. It is intended for use on GE 1.5 and 3.0T MRI systems and received FDA approval December 2012.

The results of a clinical study using the technique have been released in the Journal of Bone and Joint Surgery. The study concludes that potentially synovial volume on MRI could be used as a marker in the longitudinal assessment of asymptomatic patients with metal-on-metal hip resurfacing and in identifying patients with adverse local tissue reaction.

Source: Walter Stomp for Medgadget, 23 May 2013

Read the full article here.

CE Mark for a New Generation Drug-Eluting Stent

Tue, 21 May 2013 00:00:00 GMT

Pharmabiz hosts an article that focuses on device manufacturer Biosensors International's receipt of the CE Mark for the BioMatrix NeoFlex. The device is the newest addition to the BioMatrix group of drug-eluting stents and features an advanced stent delivery system, improving pushability, trackability and crossability. According to the article, the stent offers a lower lesion entry profile than its predecessor although it retains the same combination of abluminal biodegradable polymer coating, proprietary limus drug Biolimus A9 (BA9) and flexible platform.

Results from the final 5 year LEADERS data demonstrated that BioMatrix Flex significantly reduced the risk of clinical events in the very late phase and showed a significant reduction in very late stent thrombosis (VLST), compared with Cypher Select.

The BioMatrix NeoFlex will be rolled out in all CE Mark global markets over the coming months.

Source: Pharmabiz.com, 21 May 2013

Read the original article here.

http://www.pharmabiz.com/NewsDetails.aspx?aid=75453&sid=2

New Renal Denervation Device Significantly Reduces the Procedure Duration

Thu, 16 May 2013 00:00:00 GMT

Mass Device reports that patient enrollment has commenced for a St. Jude Medical sponsored trial to evaluate the safety and performance of a new renal denervation system (in patients with drug-resistant, uncontrolled hypertension) that will significantly reduce the total ablation process from some 24 minutes to around just 4 minutes.

The EnligHTN system delivers radiofrequency energy from an ablation catheter to create lesions along the renal nerves – a network of nerves thought to help control blood pressure. The next-generation system being evaluated in the trial reduces the procedure time thanks to an advanced intuative touch-screen generator which permits 4 simultaneous ablations via electrodes.

They say that this study expands on the research conducted in the EnligHTN I trial of the 1st generation EnligHTN system which demonstrated that patients with drug-resistant hypertension had a safe, rapid and sustained drop in blood pressure. After 30 days, systolic blood pressure was reduced by an average of 28 mmHg that remained stable with a reduction of 26 mmHg points six months after treatment.

Althought not approved in the US, the first-generation EnligHTN renal denervation system gained the CE Mark in 2012. As yet, the 2nd-generation EnligHTN system is not approved anywhere in the world.

Source: Ingrid Mezo for Mass Device, 14 May 2013

Read the full article here.

Are Economics the Cause of a Lag in the Development of Medical Devices for Children?

Mon, 13 May 2013 00:00:00 GMT

The New York Times hosts an interesting blog claiming that the development and availability of medical devices for children is a decade behind device development for adults. They say that young patients often have to go through multiple operations to resize or replace devices that no longer fit or have worn out.

Could this be down to economics? The blog refers to the pediatric market being far less sizeable than the market for adults thus making it difficult for device manufacturers to recoup R&D costs for smaller devices.

Read the article here.

Resynchronisation Device Gains a Hearty Nod from the FDA

Thu, 09 May 2013 00:00:00 GMT

Bloomberg Business Week reports that Medtronic has been granted FDA approval for its Viva permanent implant device. The product is designed to resynchronise the beating of the heart and uses an algorithm to coordinate heart contractions, adjusting to the differing demands of the body as a patient undertakes their everyday lives.

According to Medtronic, significantly more heart-failure patients responded to treatment via the Viva and they were 21% less likely to be hospitalised in the first year, than those with older devices.

Source: Michelle Fay Cortez, Reporter, Bloomberg Business Week, 06 May 2013

Read the full article here.

CE Mark for Abdominal Cavity Access Device

Wed, 01 May 2013 00:00:00 GMT

The CE mark has been awarded to Life Care Medical Devices' Keyhole Cup Laparoscopic Access Device designed to assist access to the abdominal cavity.

The initial surgical access to the abdominal region of the body has been, to date, a manual procedure involving either a veress needle or the Hassan technique. The device allows the abdominal wall to be separated from underlying organs enabling safe, fast entry of a veress needle for the introduction of inert gas prior to surgical intervention.

Source: Today's Medical Developments, 01 May 2013

FDA Approval for Soft Tissue Anchor Device

Wed, 01 May 2013 00:00:00 GMT

Orthopaedics Today reports that MedShape has received FDA approval for its Eclipse Soft Tissue Anchor. The device is designed to attach a tendon, ligament or soft tissue to bone.

According to the manufacturer's press release, the Eclipse provides a non-rotational insertion method for improved fixation strength in comparison to traditional screws and other devices. The design allows the anchor to be compressed into a compact, temporary form to allow easy insertion into a surgical area and later expand for a fixation procedure.

The Eclipse incorporates an open tip in the sheath for a suture to be fed through the implant. Its non-tapered shape provides more soft tissue compression across bone. The device is available in diameters 4-mm through 9-mm and 10-mm through 20-mm in length for use in a variety of soft tissue repair procedures in the shoulder, knee, hand/wrist and foot/ankle.

Source: Orthopaedics Today, 07 May 2013

New Fully Retractable Embolization Coil for Peripheral Vasculature

Wed, 24 Apr 2013 00:00:00 GMT

MedGadget reports that Cook Medical has launched a .035 inch embolization coil for blocking or moderating blood flow through peripheral veins and arteries. They say that the Retracta Detachable Embolization Coil is designed for more precise placement and has a radiopaque marker at the detachment point. The coil is retractable to repositon prior to detachment. (Please note that the coil cannot be reconnected once detached as suggested in Medgadget's article below).

Source: MedGadget

Read the full article here.

Read Cook Medical's press release here.

Over 500 are Recruited to the World's Largest Randomised Trial in Interventional Oncology

Mon, 15 Apr 2013 22:40:02 GMT

SIRTEX Medical Limited, a manufacturer of targeted innovative liver cancer therapies has announced the completion of patient recruitment into the group's landmark SIRFLOX randomised controlled trial of SIR-Spheres microspheres, for patients with metastatic colorectal cancer.

The SIRFLOX study is the world's largest randomised controlled trial in interventional oncology, with more than 500 patients enrolled.

Read the manufacturer's press release here (13 April 2013).

Source: www.pharmiweb.com

FDA Clears Artificial Lung System for Heart Bypass Surgeries

Wed, 03 Apr 2013 14:42:28 GMT

Medgadget reports that device medical manufacturer Medtronic has gained FDA clearance for its Affinity Fusion blood oxygenation/CO2 removal system designed for open heart surgeries. The new system build has focused on reducing bubble formation thus preventing air embolisms. The system was granted CE approval in September 2012.

A proprietary fiber winding process with an interlaced pattern filters the blood and removes particles and air whilst oxygenating the blood. Smooth tubular pathways which allow blood to pass through and a unique curved venous inlet tube can reduce blood turbulence during a surgical procedure.

Source: by Gene Ostrovsky, Medgadget, 02 April 2013

Read the full article here.

Are National Registries a Solution to Robotic Technology Evaluation & Innovation?

Tue, 02 Apr 2013 15:20:58 GMT

A recent article in the BMJ suggests that national registries may be a solution to evaluating robotic technology more thoroughly and questions what evidence is available to support the use of the technology in surgery.

It says that despite concerns over safety, effectiveness and costs, new devices and technologies for surgery are constantly and uncontrollably developed. These new technologies are often rapidly adopted with minimal scientific evidence, the da Vinci robotic system which was approved by the US FDA in 2000 being, they say, one such example.

Source: BMJ 11 March 2013

Read the article here.

Rare Risk of Damage to Heart Valve if the Device is Not Applied Correctly

Tue, 26 Mar 2013 14:07:08 GMT

Mass Device reports that Abbott Vascular has alerted clinicians on a slight risk that its MitraClip heart valve implant could be damaged if it is not applied correctly.

The manufacturer said in a field safety notice that it has received 4 reports since 2008 in which the device system's 'actuator knob' was turned in the wrong direction thus damaging the clip and preventing deployment.

Abbott's spokesman Jonathon Hamilton told MassDevice.com that these 4 cases represent only 0.05% of implantations and that the company has added a directional arrow on the actuator knob of newly manufactured devices to assist proper clip deployment.

Source: MassDevice.com, 25 March 2013

Read the full article here.

FDA Advisory Committee Votes Favorably on MitraClip

Thu, 21 Mar 2013 10:00:24 GMT

PR Newswire reports that Abbott Vascular has issued a press release announcing that the FDA's Circulatory System Devices Panel has voted by majority of 5 to 3 that the benefits of treatment with the MitraClip device outweigh its risks in patients with significant symptomatic mitral regurgitation (MR).

Abbott's MitraClip device received the CE Mark in 2008 and is an investigational device in the United States.

On a separate question of whether there is reasonable assurance the device is safe - the panel were in unamimous agreement. On the question of whether there is reasonable assurance of efficacy, 4 of the panel were in favour and 5 were not.

The FDA will now take the panel's advice into account when making its decision on whether to approve the MitraClip for the treatment of significant MR in the US, later this year.

Source: PR Newswire, 20 March 2013

Read the full article here.

Significant Blood Pressure Reduction at 24 Months After Renal Denervation System Treatment

Wed, 20 Mar 2013 12:01:02 GMT

A press release from Medtronic has announced 24 month data from Symplicity HTN-2 - the first randomised clinical trial investigating renal denervation. The data show patients initially randomised to treatment with the Symplicity renal denervation system sustained a significant drop in blood pressure. Additionally, 26 subjects in the control group who crossed-over and received renal denervation following assessment of the six-month primary endpoint had an average blood pressure reduction at 24 months.

According to the manufacturer, the 24 month average blood pressure reductions demonstrate preservation of the blood pressure reduction for both groups reported previously at 6, 12, and 18-month follow-up.

There were no device-related serious adverse events, no late vascular complications and no significant decline in kidney function compared to pre-procedure values reported out to 24 months post-procedure. The Symplicity renal denervation system is only available for investigational use in the United States and Japan.

At 24 months, pulse pressure improved significantly for patients in this analysis following treatment with the Symplicity system -18.5 mm Hg from baseline for the initial treatment group; and -22.5 mm Hg from baseline for the crossover group.

Source: Medtronic Press Office, 10 March 2013.

Read Medtronic's press release here.

See details about the Symplicity Catheter System and user comments here.

Read our November 2012 editorial article on renal sympathetic dernavation.

Insufficient Evidence on Safety & Effectiveness to achieve FDA Approval for MiItraclip

Tue, 19 Mar 2013 15:10:14 GMT

Nasdaq reports that the FDA has recommended against approving Abbott Vascular's Mitraclip heart device on the basis that they believe there is insufficient evidence to demonstrate that it is safe and effective.

The device is designed to repair heart valves in patients who are not considered to be good candidates for valve-replacement surgery.

The article says that on Monday, the FDA released a review of Mitraclip in advance of a meeting this Wednesday where an advisory committee will consider the manufacturer's application for approval. Apparently, the review recommends that the device should remain available as an investigational device so it can be used in two ongoing clinical trials where the patients are considered high-risk and inoperable.

Source: Jennifer Corbett Dooren, Dow Jones Business News, 18 March 2013.

Read the full article here.

See our details about the Mitraclip.

Infusion Catheter Systems for Peripheral Artery Disease Receive CE Mark

Wed, 13 Mar 2013 12:01:38 GMT

Massdevice reports that Mercator MedSystems' Cricket and Bullfrog micro-infusion catheters, designed for the treatment of peripheral artery disease, have gained the CE Mark.

The circulatory condition sees the build-up of plaque in the arteries resulting in reduced blood flow to extremities. The devices enable the injection of therapeutic agents through blood vessel walls into deep tissues. The catheters already have FDA clearance.

Source: Brian Johnson, Massdevice, 04 March 2013

Read the full article here.

Read more about the 2 devices in our Renal Sympathetic Denervation editorial (Chemical Ablation paragraph).

First Use of the Angel Catheter in the EU Saves a Patient's Life

Wed, 13 Mar 2013 12:44:57 GMT

The San Antonio Business Journal reports how BiO2 Medical's first triple lumen Angel Catheter, sold to a hospital in the UK, has already helped to save the life of a patient in ICU at the establishment. The device is designed to prevent pulmonary embolism in critically ill patients.

The article says that according to the manufacturer, over 25,000 people die each year from hospital-related blood clots; in the US between 200,000 and 300,000 people die annually from pulmonary embolism.

Source: James Aldridge, Web Editor-San Antonio Business Journal, 11 March 2013

Read the full article here.

Read an earlier article about the Angel Catheter.

Transcatheter Aortic Valve is CE Cleared

Mon, 04 Mar 2013 12:57:19 GMT

Medgadget reports that Medtronic's Engager transcatheter aortic valve, a prosthetic delivered via a transapical catheter for the treatment of severe aortic stenosis in patients who are unsuitable for surgical valve replacement, has gained CE approval.

The valve is composed of a nitinol frame and bovine tissue leaflets. CE clearance follows the Engager European multi-centre pivotal trial, the results of which revealed high rates of procedural success, minimal paravalvular leak (PVL) and continuing clinical benefits for patients over time.

They say that in the trial, the Engager valve was delivered transapically and had 94.3% overall device success (according to Valve Academic Research Consortium modified definitions). There were no procedures requiring a second valve and no occurrences of valve embolization, coronary obstruction or device malposition. No patients had moderate or severe PVL at six months, as measured by an independent echocardiography core lab. In addition, while most patients (88%) were NYHA Class III or IV at baseline, at six months 82% of patients had improved to NYHA Class I or II.

Source: Gene Ostrovsky, Medgadget, 01 March 2013

Read the full article here.

FDA Gives the Go-Ahead on Pulmonary Valve Trial

Wed, 27 Feb 2013 10:31:10 GMT

Mass Device covers the FDA's go-ahead on an early feasibility trial of Medtronic's Native Outflow Tract Transcatheter Pulmonary Valve (TPV). The early trial of the device will run under a new agency program for early feasibility studies. The device is designed for patients born without a right ventricle-to-pulmonary artery conduit, as an alternative to open heart surgery.

The FDA approval represents the first of its kind for the investigational device exemption following the new draft FDA guidance for early feasibility studies. The FDA issued draft guidance for IDE to encourage the development of early stage devices by incorporating clinical work much earlier in the product cycle. The aim is also to allow medical device companies to adapt the devices with appropriate agency oversight.

According to a press release from Medtronic, the study "will evaluate the design, procedural success and initial performance of the native outflow tract TPV to allow further development of the devicebefore conducting an additional clinical study."

Source: Brad Perriello, Mass Device, 26 February 2013

Read the full article here.

FDA Clears New Single Lead ICD with Atrial Sensing

Tue, 26 Feb 2013 11:06:20 GMT

Medgadget reports that medical device manufacturer, BIOTRONIK, has gained FDA approval for the Lumax 740 DX System. The implantable cardioverter defibrillator is the first in the world that will allow certain patients the benefit of atrial sensing without the requirement for a second wire to run through the heart.

They say that the system uses a Linoxsmart S DX lead which features a floating atrial dipole and algorithms that can differentiate between supraventricular tachycardias, AF and atrial flutter.

The system is compatible with BIOTRONIK’s wireless Home Monitoring platform that keeps physicians updated about any relevant events detected by the implant.

Source: Gene Ostrovsky, Medgadget, 24 February 2013

Read Medgadget's full article on the FDA's approval of BIOTRONIK'S new single lead ICD with atrial sensing.

Using Drug-Eluting Balloons for Carotid In-Stent Restenosis Shows Promising Results

Wed, 20 Feb 2013 10:00:57 GMT

Vascular News reports that two studies published in the Journal of Endovascular Therapy have concluded that the use of drug-eluting balloons to treat in-stent restenosis after carotid artery stenting shows promising preliminary results. The investigations describe, for the first time, the off-label utilisation of drug-eluting balloons for treatment of extracranial carotid in-stent restenosis.

The first paper reports on midterm results of three cases in which drug-eluting balloons were successfully used for the management of carotid in-stent restenosis. In the second, investigators wrote that, among 830 consecutive patients undergoing carotid artery stenting between November 2001 and June 2012, less than 80% in-stent restenosis occurred in 10 asymptomatic patients.

Source: Vascular News, 14 Feburary 2013

Read the Vascular News article here.

'Bionic Eye' Offers Quality of Life to Retinitis Pigmentosa Patients

Mon, 18 Feb 2013 12:06:32 GMT

Mass Device, along with several other media, reports that the FDA has granted approval on Second Sight Medical's 'bionic eye' system designed for patients with blindness due to late stage retinitis pigmentosa. The Argus II retinal prosthesis is the first 'bionic eye' to enter the US market. The device offers hope to patients who were without any available treatment options until now.

The device is comprised of an eyeglass-mounted camera and an electrical stimulator implanted in the eye. It works by converting video images captured by a miniature camera located in the patient's glasses into a series of small electrical pulses that are transmitted wirelessly electrodes on the surface of the retina.

According to the manufacturer, the pulses are intended to stimulate the retina's remaining cells resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns thereby regaining some visual function. Apparently, some patients with the disease who were only able to see bright lights experienced significant improvements in their vision.

Source: Mass Device, 14 February 2013

Read the Mass Devices article about the Argus II retinal prosthesis for treatment of blindness.

CE Approval for Implantable Cardioverter-Defibrillator

Mon, 18 Feb 2013 12:33:53 GMT

Medical device manufacturer, BIOTRONIK, has issued a press release announcing CE approval on their Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronisation therapy defibrillator (ICD/CRT-D) series.

They say that the Ilesto 7 series includes one of the world’s smallest ICDs and features ProMRI technology which enables access to potentially life-saving MR scans. And, that Ilesto offers patients and physicians the greatest longevity available - up to 11.5 years for the single chamber ICD and 7.5 years for the CRT-D device.

BIOTRONIK's press release.

Abdominal Aortic Aneurysm Stent Receives FDA Approval

Mon, 18 Feb 2013 16:14:44 GMT

Reuters reports that Lombard Medical Technologies has won FDA approval for its Aorfix AAA Stent Graft System.

The device is designed to treat abdominal aortic aneurysm disease in patients with angulations at the neck of the aneurysm, up to 90 degrees. The alternative to endovascular repair is major surgery.

Source: Reuters, 15 February 2013

Aorfix AAA Stent Graft System - read our comprehensive User Review for this device.

Drug-Eluting Stent Gains CE Mark

Wed, 13 Feb 2013 09:56:01 GMT

Mass Device reports that medical device manufacturer, Boston Scientific has gained CE approval for the Promus Premier Stent. The company plans the immediate launch of the stent in Europe.

In a press release, Boston Scientific describes the device as the only drug eluting stent to feature a platinum-chromium chassis, an everolimus coating and an enhanced stent delivery system.

The Promus PREMIER Stent System is not available for sale in the United States or Japan (as at 13 february 2013).

Source: Mass Device, 13 February 2013

Boston Scientific's Promus Premier stent is listed on Which Medical Device.

Robotic Device Assists Surgeons During Knee Resurfacing Procedures

Mon, 11 Feb 2013 12:32:57 GMT

Mass Device reports that UK based orthopaedic device manufacturer, Stanmore Implants, has achieved FDA approval for the Sculptor Robotic Guidance Arm.

According to a press release from Stanmore the system uses a robotic guidance arm to assist surgeons' operation of cutting tools during partial knee resurfacing procedures. It is one of a suite of devices and software systems that the company produces for personalised orthopedic implants.

Stanmore says it will release the system in a limited number of hospitals starting in mid-2013.

Source: Mass Device, 6th February 2013.

Read the full article here.

European TAVI Trial Includes Larger Valve

Mon, 11 Feb 2013 12:44:49 GMT

Mass device reports that St. Jude Medical is expanding its European transcatheter aortic valve implantation study to include a larger 25mm valve in the treatment of patients with severe aortic stenosis.

The manufacturer's researchers implanted the first patient with a larger sized Portico transcatheter aortic valve as part of the medical device maker's ongoing Portico TF EU trial. The trial was launched to evaluate the 23mm valve and it has now been expanded to implant up to 50 patients with the 25mm version.

St. Jude won CE Mark approval for its Portico TAVI system in November 2012. Other TAVI devices currently on the market place are produced by Edwards Lifesciences and Medtronic. Mass Device describes Boston Scientific as 'waiting in the wings along with several smaller contestants'.

Medtronic's CoreValve was the first TAVI system to launch in the European market followed by Edwards Lifesciences' Sapien. The latter beat CoreValve to the US market last year.

This year, Direct Flow Medical gained the CE Mark for its metal-free TAVI system which, according to the article, the company declares 'virtually eliminates aortic regurgitation.'

Source: Mass Device, 04 February 2013.

Read the full editorial here.

The Sapien valve was the runner-up in the Cardiology category of Which Medical Device of the Year 2012. It was joint runner-up with CoreValve in the same category, in 2011.

Renal Denervation System Receives EU Green Light

Tue, 05 Feb 2013 11:46:29 GMT

Medgadget reports that ReCor Medical, manufacturers of the ultrasound based renal denervation system for control of hypertension has received clearance for its PARADISE Gen 2 device from EU authorities. The original system was approved for sale a year ago and the new system provides an over-the-wire 6Fr device size and faster denervation.

“Our unique approach is in stark contrast to RF, which is limited in its depth of penetration to just a few millimeters, due to inconsistent arterial wall contact, as well as its inability to heat circumferentially in any given location,” said Iyer. “In addition, RF technologies generate unnecessary heating at the level of the arterial wall. Data presented at TCT 2012 concluded that renal nerves are actually much further at depth than previously thought, and run circumferentially around the renal arteries, which underscores the PARADISE ultrasound advantage.”

Source: Gene Ostrovsky, Medgdget, 29 January 2013

Read the full article here.

Read our editorial on renal denervation and the latest devices for the procedure here.

Lancet Reports on Results of a Stent Safety and Efficacy Comparison Trial

Mon, 04 Feb 2013 10:37:45 GMT

The Lancet (30 January 2013) summarises the results of a recent trial which compared the safety and efficacy of a biodegradable polymer-coated biolimus-eluting stent with that of a thin-strut everolimus-eluting stent coated with a durable biocompatible polymer.

COMPARE II was a randomised, controlled and non-inferiority trial where patients received dual antiplatelet therapy for 12 months, after discharge. From Jan 12, 2009, to Feb 7, 2011, 2707 patients (4025 lesions) were enrolled, 1795 of whom were assigned to receive the biolimus-eluting stent (2638 lesions) and 912 to an everolimus-eluting stent (1387 lesions). 2688 (99·3%) patients completed 12 months follow-up.

Significantly more patients in the biolimus-eluting stent group received a non-assigned stent than did those in the everolimus-eluting stent group (105 [5·9%] vs 19 [2·1%]; p<0·0001). The primary endpoint occurred in 93 (5·2%) patients in the biolimus-eluting stent group and 44 (4·8%) patients in the everolimus-eluting stent group at 12 months (relative risk 1·07 [95% CI 0·75—1·52]; pnon-inferiority<0·0001). Analysis per protocol did not change the outcome of this trial (pnon-inferiority<0·0001).

The trial results concluded that biodegradable polymer biolimus-eluting stents are as safe and efficacious as the current standard of a thin-strut everolimus-eluting stent with a durable biocompatible polymer. The article also says that there is a need to follow-up patients for longer to show whether the biolimus-eluting stent reduces the risk of stent thrombosis after 1 year when compared with the everolimus-eluting stent.

Read the full summary here.

Source: The Lancet, Early Online Publication, 30 January 2013

MHRA Publishes the Final Testing Results for PIP Breast Implants

Mon, 04 Feb 2013 11:34:18 GMT

The Department of Health (UK) and the MHRA have issued a statement after publishing the final testing results for PIP breast implants.

They said, "It has been a worrying time for women affected by the PIP scare. We hope it's a small comfort to women and their families to learn that the experts have examined all the available evidence and concluded that the silicone contained in PIP breast implants does not pose a risk to human health.”

The MHRA's website hosts details of the toxicology testing and collection of clinical findings on removal of the implant and a final expert report on PIP breast implants (the latter links to the DH website).

You can link to them both, here.

Source: MHRA, 1st February 2013

FDA to Get Tough on All-Metal Hip Implants

Mon, 28 Jan 2013 11:39:51 GMT

Arthritis Today (US) reports that the FDA is proposing to introduce new rules that would require manufacturers of metal-on-metal hip-replacement implants to either prove their products are safe or stop selling them. A high level od early failure rates and the shedding of microscopic metal particles in the body have led to calls for stricter regulation of the devices.

Under the proposals, manufacturers would have 90 days to submit data showing that an implant is safe and effective. Metal implants that don’t meet these requirements would be removed from the market.

There will be a 90 day comment period where manufacturers, the public and others can submit their views about the new rules which will be reviewed by the FDA. The whole process is anticipated to take around a year.

Source: Linda Rath, Arthritis Today, 28 January 2013.

Read the full article here.

FDA Considers a Downgrade of the Regulatory Status for Scleral Plugs

Mon, 28 Jan 2013 12:30:57 GMT

Massdevice reports that the FDA has issued a proposed rule that would exempt certain scleral plugs from the 510(k) regulatory process after deciding that the devices don't need the extra safety and effectiveness controls where they are made of stainless steel. The plugs are used to temporarily close incisions made in the eye during surgical procedures.

They say that the FDA has concluded that pre-market notification, or a 510(k) submission, is unnecessary to determine the safety and effectiveness of the devices, so long as they are made of surgical grade stainless steel with or without a gold, silver or titanium coating - according to a report in the Federal Register.

The advisory panel recommended that the FDA downgrade stainless steel plugs to Class I, or general controls, because biocompatibility and sterilisability had already been established.

The agency is gathering public comments on the potential downgrade up until April 25, 2013.

Source: Massdevice, 25 January 2013

Read the full article here.

Guidance System Reduces Complexity and Cost of Knee Replacement Procedures

Thu, 24 Jan 2013 11:24:11 GMT

RTT News reports that Zimmer Holdings has received FDA clearance for the company to market iASSIST Knee, a personalised guidance system for knee replacement procedures.

The iASSIST Knee comprises small electronic disposable pod components and provides accurate alignment validation through an electronic display at the site of the knee replacement surgery.

According to the manufacturer, the iASSIST Knee enables accurate positioning and alignment of a knee implant as an alternative to more complex and costly intensive navigation and robotic systems.

Source: RTT News, 17 January 2013

Read the original article here.

Computerised System to Control Anaesthetic Delivery

Wed, 23 Jan 2013 10:16:49 GMT

Expressindia reports on a closed loop anaesthesia delivery system (CLADS) which controls anaesthetic drug delivery automatically based on the feedback of its effect on the patient.

The device has been developed at PGI under a project funded by the Department of Information Technology, New Delhi. The device has also been patented and recently underwent a multicentre evaluation at 6 hospitals.

The computer controlled anaesthesia has been used in PGI for open heart surgeries, major non-cardiac surgeries and also in high altitude. This system has been patented in the US, Europe and India. They say that CLADS would help save the time spent on adjusting the depth of anaesthesia and enable the clinician to devote his time on other interventions.

The project ‘Multi-centric Evaluation of Closed Loop Anaesthesia Delivery System’ was approved by the Department of Information Technology (DIT) in December 2008. This was undertaken by 6 centers, including at Sir Ganga Ram Hospital, New Delhi, the Government Medical College and Hospital, Sector 32, Chandigarh, the Dayanand Medical College and Hospital in Ludhiana, SNM Hospital, Leh, GMCH, Patiala and at PGIMER, Chandigarh. The study was completed in November 2012.

Source: expressindia.com, 23 January 2013

Read the full article here.

CE Mark for Two St. Jude Devices

Wed, 23 Jan 2013 10:33:14 GMT

Zacks Equity Research reports that St. Jude Medical has received CE Mark approval for the Amplatzer Amulet Left Atrial Appendage Occluder and the ViewFlex Xtra Intracardiac Echocardiography Catheter. The devices were first unveiled at the 18th annual Boston AF Symposium.

According to he manufacturer, the advanced Amulet cardiovascular device is further advanced than the original Amplatzer Cardiac Plug because it can be used to treat a wider range of appendage anatomies. The percutaneous transcatheter device is intended to seal off left atrial appendage in patients ailing from non-valvular atrial fibrillation. The device has not yet been cleared by the FDA.

The ViewFlex Xtra ICE Catheter has received the CE Mark and it is already FDA approved. The catheter allows seamless movement during cardiac ablation surgeries with the aim of enhancing clinical outcomes. Along with the ViewMate Z Intracardiac Ultrasound Console, the device provides real-time image guidance and visualisation of a patient’s cardiac anatomy. It is capable of delivering fast, high-fidelity images.

Source: Zacks Equity Research, 22 January 2013.

Read the full article here.

FDA to Host a Public Workshop on Standardised Medical Device Labelling

Tue, 22 Jan 2013 10:53:22 GMT

Insidemedicaldevices.com reports that the FDA will host a 2-day public workshop in April where the organisation aims to obtain feedback from stakeholders about standardising medical device labelling and creating a publicly available repository of device labelling.

They say that improving the accessibility and usefulness of medical device labeling is a strategic priority of the Center for Devices and Radiological Health (CDRH) this year. As part of the agency’s efforts, in May 2011, the FDA published the results of a focus group study with health care practitioners exploring provider satisfaction with current device labelling and potential changes. Focus group participants expressed the need to revise device labeling to make it concise and simple. Caregivers who use home use devices were also surveyed from October 2011 through January 2012 and expressed a desire for standardised labelling with access to a “quick guide” with instructions for use.

The FDA has already taken steps towards an online repository of medical device labelling for home use devices. They had expressed concern about the safe use of devices in the home and launched the Home Use Devices Initiative in 2012. it was through this initiative that the FDA stated that it will develop an online labeling repository for devices approved or cleared for home use.

If you are interested in attending or making a presentation at the workshop, you must register by April 5. The workshop will also be live webcast if you cannot attend in person. The FDA is accepting written comments until April 12, 2013.

Source: Afia Asamoah, Insidemmedicaldevices.com, 17 January 2013

Read the original article here.

European Study Compares Patient Outcomes of Two Leading TAVI Devices

Tue, 22 Jan 2013 11:20:58 GMT

Cardiac Interventions Today reports on results from the PRAGMATIC Plus Initiative (Pooled-Rotterdam-Milano-Toulouse In Collaboration) that were published online ahead of print in the Journal of the American College of Cardiology.

The study aimed to compare the patient outcomes of TAVI, using the Medtronic CoreValve versus the same procedure using the Edwards Sapien XT transcatheter heart valve. No differences were observed between the two devices at the adjusted analysis in Valve Academic Research Consortium outcomes. The exception was for the need for permanent pacemakers with the MCV.

The study included 793 patients, of whom 57.1% were treated with the MCV and 340 42.9% were treated with the ESV. Following propensity matching, 204 patients were identified in each group. At 30 days, there were no differences in all-cause mortality, cardiovascular mortality, myocardial infarction, stroke, or device success. Additionally, there were no differences in major vascular complications or life-threatening bleeding. MCV was associated with more permanent pacemakers. At 1 year, there were no differences in all-cause or cardiovascular mortality.

Source: Cardiac Interventions Today

Clinical Trial in India & Europe for Mitral Regurgitation Device

Wed, 16 Jan 2013 11:41:20 GMT

Redorbit reports on a press release from Phoenix Cardiac Devices which announces the start of a clinical trial in India and Europe that will test their BACE device for the treatment of mitral regurgitation without open heart surgery. Apparently, the manufacturer has enrolled its first patient in a clinical trial aimed at achieving CE Mark approval in Europe.

They say the the trial will assess the safety and efficacy of the BACE device which is an adjustable tension band that encircles the heart and supports the mitral valve leaflets so they close properly to prevent the back flow of blood into the heart.

Previous studies of BACE, including a proof of concept study in 12 patients and a feasibility study in 14 patients, demonstrated a significant reduction in mitral regurgitation and no device-related serious adverse events following implantation. Results of the proof of concept study were published in the Australian journal, Heart, Lung and Circulation in December, 2009. The current study will enroll 60 patients in India and Europe who have moderate to severe functional mitral regurgitation.

The BACE can be remotely adjusted from an external port and its efficacy can be assessed through real-time echocardiography whih allow immediate adjustments in tension and pressure.

Source: Redorbit.com, 14 January 2013.

Read the full article here.

The Advance of Robotic Surgery

Wed, 16 Jan 2013 12:37:12 GMT

An interesting article from Fortune covers the advancing use of robotics for standard operating procedures. It follows a 71 year old patient's experience of a machine that went inside him, navigated the space beneath his rib cage, cut and cauterised and then sewed two of his arteries back into his heart.

The machine was the da Vinci which is patented and manufactured by Intuitive Surgical (ISRG). The da Vinci includes a console, a robot and a tall server bay that connects them. Intuitive has developed a closed model: Its software and hardware are proprietary and the company controls all aspects of the da Vinci's production.

The article claims that surgeons have 'adopted robotics in droves' and that patients are also driving demand. They say that last year the Journal for Healthcare Quality reported that 41% of hospital websites advertised robotic surgery and of these, 37% did so on their homepage. Hospitals with robots are pulling in more and more patients and in some cases the existence of the robot actually increases the number of surgeries performed.

Source: Ryan Bradley, Senior Editor, Fortune, 15 January 201.3

Read the full article here.

FDA Approves LED Light Therapy Device

Mon, 14 Jan 2013 13:07:11 GMT

BioOptics World reports that US biophotonic device developer BioPhotas has received FDA clearance of its Celluma light emitting diode (LED) light therapy device. It has been designed for acne treatment, muscle and joint pain, muscle and joint stiffness, muscle spasm, arthritis and compromised local blood circulation.

They say that research funded by the National Aeronautics and Space Administration and the Defense Advanced Research Projects Agency, using LEDs or biophotonic therapy, has been proven in clinical trials to up-regulate cellular function in the treatment of a number of common conditions, restoring the body's natural ability to heal itself.

In some other therapies, tissue is intentionally damaged to create a healing response whereas LED light can re-energise cellular function in a non-invasive manner.

The Celluma device uses three wavelengths of LED light energy, modulated with proprietary electronic algorithms.

Source: Lee Mather, Associate Editor, BioOptics World, 10 January 2013.

Read the original article here.

FDA Approves Spinal Implant Devices

Mon, 14 Jan 2013 12:14:56 GMT

The Orange County Business Journal reports that medical device manufacturer, VertiFlex, has received FDA clearance on two spinal implant devices. The company produces less-invasive medical devices for treating a range of spinal diseases.

The devices are the Univise Spinous Process Fixation device and the Totalis Direct Decompression device which have been designed to assist surgeons performing lumbar spine decompressions.

Source: Vita Reed, Orange County Business Journal, 11 January 2013.

Read the original article here.

Clinical Trial Commences for Drug Eluting Stent

Mon, 14 Jan 2013 12:00:29 GMT

Massdevice reports that medical device manufacturer Abbott has initiated the Absorb III clinical trial which will evaluate its drug-eluting bioresorbable stent in patients with coronary artery disease. According to a press release from the company, the stent is made of polylactide, a naturally dissolvable material.

The article says that 2,250 patient trial will compare target lesion failure rates between Absorb and Abbott's market-leading Xience drug-eluting stent which received FDA clearance this month and CE Mark approval in August last year.

Abbot also intends to evaluate vasomotion of some patients, measuring whether natural motion returns to the vessel after using the Absorb device.

Source: Massdevice, 10 January 2013

Read the full article here.

US Research Demonstrates that Defibrillators Live Up to Clinical Trials

Wed, 09 Jan 2013 12:03:49 GMT

Futurity hosts an article on a study published in the Journal of the American Medical Association which used data from a large national Medicare registry to assess the survival of patients receiving defibrillators which are used to prevent sudden cardiac death.

It says that because clinical trial participants tend to receive more meticulous care while also being healthier than patients seen in clinical practice, the actual benefits of new drugs and medical devices can be less positive than initially reported. Not so, they say, for the defibrillators, at least when comparing patients with similar characteristics in both the clinical trials and real-world practice.

Lead author Sana M. Al-Khatib, an electrophysiologist and member of the Duke University Clinical Research Institutev said, “We showed that patients in real-world practice who receive a defibrillator but who are most likely not monitored at the same level provided in clinical trials have similar survival outcomes compared to patients who received a defibrillator in the clinical trials.”

Implantable cardioverter-defibrillators (ICDs) have been lifesavers for people with a history of cardiac arrest or heart failure. The small electrical devices are implanted in the chest with wires that lead into the heart, sending an electronic pulse when the heart stops beating to reestablish a normal rhythm.

To monitor treatment patterns, effectiveness and safety of ICDs among Medicare patients in the US, the Centers for Medicare & Medicaid Services mandated that data on all Medicare patients receiving a primary prevention ICD be entered into a national registry. A national ICD Registry has been collecting data from hospitals performing implantations since 2005.

The Duke-led research group used data from that registry to compare more than 5,300 real-world patients against more than 1,500 patients who had enrolled in two large clinical trials of ICD devices. By comparing similar populations, researchers were able to address the concern that outcomes reported in clinical trials are overly optimistic.

Source: Duke University (hosted on Futurity.org), 07 January 2013.

Read the full article here.

FDA Approves Graft for Rotator Cuff Repair

Wed, 09 Jan 2013 12:14:32 GMT

Haelio reports that Soft Tissue Regeneration has gained FDA approval for its STR Graft which can be used for soft tissue augmentation and rotator cuff repair.

They say that according to a company press release, the graft is a 3-D matrix which is similar to a patch and it can be draped over a tendon which sits on the shoulder bone. The graft is anchored with sutures to keep it in place during surgery while the tendon, bones and nearby tissues heal.

The device, which is expected to be on the marketplace in 2014, is mooted for reducing pain, speeding-up recovery time and reducing surgical failure rates.

Read the original article here.

Source: haelio.com, 04 January 2013

World Health Organisation Calls for Innovative Health Technologies Ideas

Mon, 07 Jan 2013 11:18:48 GMT

The Medical Devices and eHealth units of the World Health Organisation are inviting submissions about innovative medical devices and eHealth solutions for low-resource settings. Selected submissions will be published in the WHO Compendium of innovative health technologies 2013.

The deadline is 15th March 2013.

Click here for more details.

CE Mark for New Mitral Valve Repair Technology

Mon, 07 Jan 2013 11:36:50 GMT

The Wall Street Journal reports that NeoChord has announced that it has received a CE mark for its DS1000 System that allows the implantation of artificial chordae tendinae for the repair of mitral valve prolapse via a transapical off-pump procedure.

The manufacturer has also started the 50 patient Transapical Artificial Chordae Tendinae Registry, with first commercial European procedures scheduled for the first quarter of 2013.

They are described as "meaningful steps forward in the treatment of patients with severe mitral regurgitation," said Dr. Giovanni Speziali, the primary inventor of NeoChord's technology. He goes on to say that "The NeoChord procedure allows patients an alternative to still undergo a quality repair without enduring the rigors of traditional treatment via open-chest surgery performed on a stopped heart."

NeoChord is a privately held medical technology company focused on advancing the treatment of mitral regurgitation.

The NeoChord device is not available for commercial use in the US.

Source: Wall Street Journal, 4th January 2013.

Read the full article here.

Read Which Medical Device's editorial on mitral valve repair.

30,000 of Donations Place 187 Oximeters in Low Resource Hospitals

Mon, 07 Jan 2013 11:02:20 GMT

The BMJ website hosts details of their readers' response a Lifebox Foundation Christmas Appeal, the results of which put 187 pulse oximeters into operating theatres in 10 low resource countries.

Over £30, 000 was donated over just a few weeks and it was used to send oximeters and education materials to hospitals from Cambodia to Cameroon, Nepal to Nicaragua, Papua New Guinea to the Philippines. In these countries, surgery regularly takes place without any monitoring equipment beyond a manual blood pressure cuff or a finger on the pulse. In this setting therefore, a pulse oximeter is a vital component of safe surgery.

The Lifebox oximeter has an audible tone that drops as a patient’s oxygen saturation decreases. In the past year, the changing of the beep has identified internal haemorrhage during emergency caesarean sections while there was still time to act, been the eyes and ears of the surgical team in a suddenly dark operating theatre when the generator failed again, and alerted an anaesthesia provider to an oesophageal intubation; in short, oximeters have had a direct effect on the safety of surgical care.

Abayehu Haile, an anaesthesia provider at Limmu Geenet Hospital, Ethiopia is quoted as saying, “When you come to my profession, pulse oximetry is the heartbeat for my work, for safe surgery,” Haile told us. “But I couldn’t ever say—‘we have no monitor’ and refuse to work—I had no choice but to try to save life as best I could. Now thanks to you, we are using the oximeter and the World Health Organisation Surgical Safety Checklist in our hospital. I would like to thank you again and again for your impressive life saving activity. You are not only supporting patients, you are also helping professionals.”

Source: Sarah Kessler, Project Manager, BMJ

Read the full article here.

US Cardiologist Calls for More Data on FDA Approved Defibrillator

Thu, 03 Jan 2013 15:35:43 GMT

Medgadget reports that US cardiologist Dr. Robert Hauser, has recommended that doctors need more data on the safety and effectiveness of Boston Scientific's FDA approved lead-free implantable defibrillator, S-UCD, before using the device.

Apparently, it is the world's only commercially available lead-free implantable cardioverter defibrillator that delivers heart rate managing electrical shocks without needing wires threading through blood vessels. Implanted just under the skin, this less invasive procedure opens up the treatment to a wider range of patients.

The article quotes from Hauser's submission in the January issue of the Journal of the Americal College of Cardiology where he wrote, "The S-ICD has not yet been shown to be safe and effective in a diverse patient population." He also said that, "Unless critical questions with regard to safety and efficacy in primary and secondary prevention are addressed, the S-ICD should be confined to certain subgroups."

Boston Scientific inherited the S-ICD technology last summer (2012), when it bought-out Cameron Health.

Source: 02 Medgaget 2013

Read the full article here.

New Cutter/Stapler Device Available in Europe

Thu, 03 Jan 2013 16:05:01 GMT

Medgadget reports that Cardica is releasing its MicroCutter XCHANGE 30 cutting/stapling device to the European market. The dual use device, intended for use in laparoscopic and thoracoscopic procedures, allows surgeons to deliver multiple staples without needing to reload cartridges.

The company received CE Mark clearance for the device in March 2012 and will start the roll-out from hospitals in Switzerland and Austria.

The article says that around 60 surgeons have used the XCHANGE 30 in over 220 laparoscopic and thoracoscopic procedures with more than 600 deployments over the last 8 months. The device has been used in a variety of procedures including appendectomies, gastric bypasses, hemicolectomies, gastrectomies, parenchymal or soft organ surgeries (operations on the liver and kidney), lobectomies and other thoracic and lung surgeries. It has also been used during hysterectomies.

Source: Gene Ostrovsky for Medgadget, 02 Jan 2013.

Read the article here.

Spine Implant Devices Approved for Japanese Market

Thu, 20 Dec 2012 12:02:46 GMT

MassDevice reports that the Japanese regulatory body has approved NuVasive's 2 titanium alloy implants for sale in the world's second largest spine market.

The manufacturer's CoRoent large impacted and CoRoent large tapered titanium alloy implant devices are designed for use in posterior spine fusion procedures. They are the first of NuVasive's inter-body fusion cages to be approved in Japan.

According to the company website, the devices are used for anterior cervical inter-body fusion and indicated for single-level reconstruction of degenerated cervical discs from the C2-C3 to C7-T1 vertebrae after discectomy.

The CoRoent received FDA clearance in March 2012. In October, the company achieved FDA approval for its PCM cervical disc system designed to preserve motion in the cervical spine in lieu of a standard fusion procedure.

Source: MassDevice, 17 December 2012

Read the original article here.

Bare Metal Coronary Stent is Implanted in First US Patients

Thu, 20 Dec 2012 12:25:07 GMT

Medgadget reports that Biotronik's Pro-Kinetic Energy stent has been implanted in US patients.

The bare metal coronary device is made from cobalt chromium that enabled the creation of struts with a 60μm (0.0024 inch) width. It’s also coated with an amorphous silicon carbide that limits the release of ions from the stent, potentially reducing the volume of platelets gathering around the stent and helping with endothelialisation.

They say that the cobalt/chromium construction permits greater flexibility and a narrower crossing profile over commonly used nitinol stents. The Biohelix-I trial is a prospective, nonrandomized, multicenter, investigational device exemption study that will use the stent system in patients with symptomatic ischemic heart disease.

Saurabh Gupta, MD, director of the Cardiac Catheterisation Laboratory at Oregon Health & Science University in Portland, Oregon, is the National Principal Investigator of the Biohelix-I study. He is quoted as saying, “The thin cobalt chromium struts of the Pro-Kinetic Energy allow for greater flexibility and a reduced crossing profile which translates into a highly-deliverable stent.”

Source: by Gene Ostrovsky for MedGadget, 19 December 2012.

Read the full article here.

Brain-to-Machine Interface May Offer a Way Forward for Neurological Control of a Prosthetic Limb

Wed, 19 Dec 2012 14:28:23 GMT

The Lancet features an interesting report about how brain-to-machine interfaces could provide the way forward for restoring lost functions for an individual with tetraplegia. This type of interface, they suggest, could quickly achieve neurological control of a high-performance prosthetic limb.

During a clinical test, two intracortical microelectrodes were implanted in the motor cortex of a 52 year old individual with tetraplegia. Brain-machine-interface training followed over a 13 week period with the aim of controlling a prosthetic limb with seven degrees of freedom. Their ability to control the limb was assessed with clinical measures of upper limb function.

After 13 weeks, seven-dimensional movements were performed routinely. The mean success rate on target-based reaching tasks was 91·6%; improvements were seen in completion time and path efficiency increased. The participant was also able to use the prosthetic limb to do skilful and coordinated reach and grasp movements that resulted in clinically significant gains in tests of upper limb function. No adverse events were reported.

They say that with continued development of neuroprosthetic limbs, individuals with long-term paralysis could recover their natural and intuitive command signals for hand placement, orientation and reaching thereby allowing them to increase their independence by being able to perform activities of daily living.

Source: The Lancet, 17 December 2012.

Read the article here.

CE Mark Approval on Device that Protects Critically Ill Patients from Pulmonary Embolism

Fri, 14 Dec 2012 11:22:15 GMT

Pharmabiz.com (India) reports that medical device manufacturer BiO2 Medical has received CE Mark approval for its triple lumen Angel Catheter. The device is described as a nitinol inferior vena cava filter, permanently attached to a central venous catheter, for the use of preventing pulmonary embolism in critically ill patients.

Apparently, the catheter provides instant protection from PE and is the first IVC Filter to receive CE Mark approval for prophylactic indications.

Source: Pharmabiz.com, 11 December 2012

Read the full article here.

FDA Clears Intravascular Object Retrieval Device

Wed, 12 Dec 2012 10:55:08 GMT

Medgadget reports that the FDA has approved Merit Medical's ONE Snare Endovascular Snare System. The manufacturer describes the device as designed to retrieve inferior vena cava filters, reposition indwelling venous catheters, strip fibrin sheath formation, or assist in central venal access venipuncture.

The loop of the snare is Nitinol coated with a layer of gold plated tungsten so that it is both flexible and clearly visible under a fluoroscope during vessel navigation.

The article includes several of the device's features detailed in the manufacturer's brochure which includes a 90 degree angle loop for a coaxial approach to capture foreign bodies. There is also an accompanying video. Your can read the fullarticle and access the video by following the link below.

Source: Gene Ostrovsky for Medgadget, 11 December 2012

Read the article and watch the video here.

Pacemaker Styled Device is Studied in Alzheimer's Treatment

Mon, 10 Dec 2012 11:42:54 GMT

CBS (US) reported on new research about device for the brain which is similar to a pacemaker that may offer a more effective way to treat Alzheimer's disease. Dr. Paul Rosenberg, a specialist at Johns Hopkins University talked to "CBS This Morning" about the treatment's first clinical trial.

You can watch and listen to the news report here.

Source: CBS News

'Ready-to-Use' TAVI System is Implanted in First Patient

Mon, 10 Dec 2012 11:32:57 GMT

Medgadget reports that a 'ready-to-use' TAVI system has been successfully implanted in a human patient at the Center of Advanced Medicine (CEDIMAT) in Santo Domingo, Dominican Republic.

They say that the Colibri Heart Valve is delivered through a 14 French introducer, apparently the smallest in the industry, which allows its use in patients with narrow vasculature and more difficult anatomies. The current device is 24mm in size with 21mm and 27mm diameters being in development. The device has a folded valve which is designed to maximise its durability and reduce the suture.

Apparently, Colibri has conducted extensive pre-clinical testing on its heart valve technology, including successful accelerated wear testing to over 200 million cycles. The device's porcine pericardial tissue has been tensile tested against competitors' traditional “wet” valve tissues and was found to be 3.5 times stronger in the tests.

Source: Gene Ostrovsky for Medgadget, 06 December 2012

Read the full article here.

New Repair Device for Consistent Placement of Sutures

Thu, 06 Dec 2012 14:18:49 GMT

MedGadget reports that medical device manufacturer, Covidien, has released the AS Meniscal Repair Device which is designed to deliver consistent placement of sutures. They say that the device can be used for “all-inside” arthroscopic surgeries when repairing torn minisci using the “all-suture” fixation method.

Covidiens's press release includes a quote which says that the device, "...enables surgeons to leverage the value of using the gold standard all-suture approach in a less invasive arthroscopic fashion.”

Apparently, tests conducted by Covidien have proven that the AS Meniscal Repair Device deploys sutures with strong holding power consistently and reliably without the need for anchors. They say that the new device works with one thumb slide actuation and that it has no complex components. It features laser-etched depth markings on the coated curved and straight versions of needles.

Source: Gene Ostrovsky for MedGadget, 05 December 2012

Read the original article here.

FDA to Work With Industry Consortium on Speeding Up Medical Device Approval Procedure

Tue, 04 Dec 2012 10:17:05 GMT

The Star Tribune (US) reports that the FDA intends to collaborate with medical device manufacturers on a public-private partnership basis in order to quicken the development of new medical technology. The FDA aspires to offer guidance to the Medical Device Innovation Consortium which includes companies such as Medtronic, the Mayo Clinic and the University of Minnesota that is driving to simplify the design and testing of medical devices.

A quote from the FDA acknowledges that many medical device companies are small businesses that may not have the research budgets to find more effective ways of testing their devices.

The article says that the FDA's pledge follows criticism from industry supporters who have claimed that the FDA's overly burdened system of reviewing devices may have lead to some companies going out of business as well as slowing down the development of new treatment options.

Apparently, the FDA has been making recent attempts to reduce red tape and hasten review times.

Source: Star Tribune, 03 December 2012

Read the original article here.

Brain Pressure Monitor to be Trialled

Tue, 04 Dec 2012 10:44:41 GMT

An article in the Winsconsin State Journal (US) reports on a medical device that enables doctors to externally monitor brain pressure in children with hydrocephalus - a condition where the body is unable to reabsorb the spinal fluid that bathes the brain.

Apparently, the device avoids the patient having to go through invasive surgery with the implant sending signals about brain pressure to a hand held scanner. They say that the implant was invented at UW Hospital by a neurosurgeon and it will now be trialled in animals with human trials expected to follow within 1.5 to 2 years.

Source: Ron Seely, Winsconsin State Journal, 02 December 2012.

Read the original article here.

No Shock at CE Mark Approval for Range of ICDs

Thu, 29 Nov 2012 12:24:13 GMT

An article in the US Star Tribune reports that medical device manufacturer, St. Jude Medical, has achieved the CE Mark for the company's range of Assura implantable cardioverter defibrillators. The devices are designed to deliver high levels of energy to the heart while minimising unexpected shocks.

According to St. Jude Medical, the ICDs can generate 40 joules of energy which they say is the highest amount of energy that can shock a heart back into rhythm. Apparently, the devices also feature an algorithm based technology to prevent them from accidently shocking the heart.

Source: Thomas Lee, Star Tribune, 28 November 2012.

Read the original article here.

CE Mark for Stent that Mimics the Shape of the Vascular System

Tue, 27 Nov 2012 15:57:52 GMT

Massdevice reports that UK medical device company, Veryan, has received CE Mark approval for the BioMimics 3D stent, designed to treat superficial femoral and proximal popliteal arteries of the leg. According to the manufacturer, the device features a 3-dimensional design which mimics the natural shape of the human vascular system and thereby reduces kinking, deformation and potential vessel trauma during leg flexion.

Apparently, the CE approval was based on Veryan's MIMICS study which compared the safety and efficacy of the BioMimics 3D stent with a standard nitinol stent in patients with peripheral artery disease, with follow-up at 6 and 12 months. They say that the data showed all 50 enrolled patients were free from clinically driven target lesion revascularisation when using BioMimics 3D stent. There were no deaths or amputations.

Source: Massdevice, 23 November 2012

Read the original article here.

50 Years of Hip Replacement Surgery!

Mon, 26 Nov 2012 14:31:28 GMT

The Healthcare Quality Improvement Partnership reports on how hip replacement surgery celebrated its 50th anniversary on 23rd November.

The National Joint Registry has monitored the performance of hip replacement implants since 2003 and they say that the organisation, which is approaching its 10th anniversary, now holds a rich data resource that can offer robust analysis of the performance of implant devices and effectiveness of surgical technique.

A quote from NJR National Lead Elaine Young reads, "We are reminded today of the significant contribution hip replacement surgery has made to quality of life for so many people. The NJR's role is to ensure that continues to happen. Through the collection of data and the monitoring of implants, surgeons and hospitals, we are able to support the improvement of joint replacement surgery for patients."

You can read the full article here.

FDA Approves Life-Saving Heart Pump

Thu, 22 Nov 2012 09:55:09 GMT

Reuters reports on FDA approval for a heart pump manufactured by HeartWare International Inc. The device is designed to support blood flow in patients with with failing hearts who are awaiting a transplant. They say that the left ventricular assist device (LVAD) can be implanted in the chest near to the heart and used inside or outside a hospital.

Apparently, the FDA said the life-saving benefits of the device outweighed risks observed during the clinical trial, such as infection and stroke. The heart pump is already sold in Europe.

The FDA approval was based on data from a study of 137 patients with advanced heart failure who received the HeartWare LVAD. The data was compared with outcomes from patients followed by a medical database who used other mechanically assisted circulatory support systems. The article says that this is the first time that the FDA has approved an LVAD using information from a database as a comparison.

Source: Susan Kelly, Reuters.com, 20 November 2012

Read the full article here.

TAVI Heart Valve Wins CE Mark

Tue, 20 Nov 2012 11:39:20 GMT

Medcitynews reports on CE Mark approval for St. Jude Medical's Portico TAVI system for patients who are too unwell to undergo open heart surgery to replace diseased heart valves.

The 23 mm Portico TAVI valveis described by the manufacturer as the 'only approved transcatheter valve that can be completely resheathed, repositioned at the implant site or retrieved before it is released from the delivery system.'

Apparently, the device was designed to address one of the more common problems with first generation TAVI valves – paravalvular leak, a post-operative complication where blood flows through a channel between the implanted heart valve and the cardiac tissue because the prosthetic valve has not been sealed properly.

The article says that a CE Mark for a 25 mm TAVI valve is anticipated by the end of the year.

Read the original article here.

An article was also published in Medgadget, on 21 November 2012.

Latest Anaesthesia Monitor Introduced in Kenya

Tue, 20 Nov 2012 11:16:54 GMT

Standardmedia reports that the Carestation 30, manufactured by GE Healthcare, is the latest anaesthesia monitor to be introduced in Kenya. The machine integrates the level of oxygen in the blood and other key measurements into its delivery system.

They say that the device delivers calibrated mixtures of gases and oxygen to the patient to sustain anaesthesia while also providing patient monitoring capabilities to allow the anaesthesiologist or technician caring for the patient to make adjustments as necessary during the procedure.

Apparently, the machine can be hooked up to wall supplies of oxygen and other gases as well as reserve cylinders kept for emergencies.

Source: Rawlings Otieno, standardmedia.co.ke, 20 November 2012

Read the full,original article here.

FDA Approves Unique Drug-Eluting Stent for Peripheral Artery Disease

Mon, 19 Nov 2012 11:44:02 GMT

Medcitynews reports that Cook Medical has received FDA approval for the first drug-eluting stent to treat peripheral artery disease in the US. The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding metal stent coated with the drug paclitaxel to help prevent recurring narrowing of the artery.

Drug-eluting stents are currently approved for use in coronary arteries in heart attack patients. They say that whilst Boston Scientific, Abbott Laboratories and Medtronic lead the market, Cook’s device is the first of its kind for peripheral arteries. The stent received CE Mark approval in 2009 and it is distributed in over 50 countries.

Apparently, the device is designed specifically to re-open the femoropopliteal artery in the thigh when the artery is narrowed or blocked as a result of PAD. The FDA provided that the approval expands treatment options for patients with PAD beyond existing therapies that include exercise, drug therapy, percutaneous transluminal angioplasty or bare-metal stenting.

The article goes on to say that Cook must now conduct a 5 year post-approval study of 900 patients treated with the stent to further monitor safety and efficacy. The stent will initially be available in 80 mm lengths in 6 mm and 7 mm diameters and Cook plans to offer a suite of the most commonly used lengths and diameters by the end of 2013.

Source: Deanna Pogorelc, Medcitynews.com, 15 November 2012

Read the full, original article here.

Interesting Survey Results on the FDA's Process

Wed, 14 Nov 2012 11:38:44 GMT

Medcitynews reports on a survey commissioned by the MedTech Resource Alliance that invited 2707 medical device manufacturers to share their experiences of the FDA’s 510(k) pathway. Of the 129 companies that responded, 64% indicated that they are either “extremely dissatisfied” or “somewhat dissatisfied.” The groups that report the highest dissatisfaction are ophthalmic, neurological and ENT device companies. Those with the highest satisfaction manufacture cardiovascular devices, infection-control and dental devices and devices for anesthesiology and hospitals.

Apparently, the main reason for dissatisfaction is a delay in communication, especially if the FDA ultimately ruled that a product could not be cleared because it wasn’t substantially equivalent to a product currently available in the market.

The article goes on to say that another area of concern is what device makers perceive as 'a lack of scientific expertise' at the FDA.

Read the full article here.

Read the survey report here.

Source: Arundhati Parmar, Medcitynews.com, 12 November 2012

MHRA Consultation on Regulation of Medical Devices

Wed, 14 Nov 2012 13:42:24 GMT

AnaesthesiaUK hosts details about how the Medicines and Healthcare products Regulatory Agency is calling for healthcare professionals and the public to share their opinions on new draft European laws for the regulation of medical devices including breast and hip implants.

The information provides that the MHRA has been pressing the European Commission to strengthen their regulation system and a 10-week consultation is currently taking place courting views on whether the new draft legislation goes far enough in promoting the safety of medical devices, improving the bodies that assess the safety of medical devices and ensuring transparency and improved collaboration across national regulators.

Read the original article here.

You can take part in the consultation at the MHRA website.

Source: AnaesthesiaUK, 13 November 2012

Device Offers Faster Recovery for Female Uterine Fibroid Patients

Thu, 08 Nov 2012 10:03:53 GMT

Medcity News reports that US medical manufacturer, Halt Medical, has gained FDA clearance for its Acessa device that gynecologists can use to treat female uterine fibroids.

They say that the device uses RF ablation to treat just the fibroids and is an alternative to traditional fibroid surgery where tissue layers are cut through in order to access a tumor or to remove the uterus. The procedure has already been approved in Europe and Canada.

Apparently, the National Uterine Fibroids Foundation estimates that up to 6 weeks of work is lost in recovery times following a hysterectomy. The manufacturer claims that treatment via the Acessa means that patients can go home the same day and resume all normal activity in 5 days or less.

Source: Arundhati Parmar, Medcity News, 6 November 2012

Read the original article here.

Medical Transcatheter Aortic Valve Fares Well in Clinical Study

Tue, 06 Nov 2012 11:35:04 GMT

Medgadget reports on promising results arising from a clinical study of Direct Flow Medical's Transcatheter Aortic Valve System. They say that the device achieved its primary mortality endpoint and that over 95% of patients had mild or less aortic regurgitation. No patients experienced vascular complications.

The valve is made of a polymer frame, bovine pericardium leaflets and 2 inflatable rings that sit on both sides of the patient’s own valve. The rings can also deflate and the valve can be repositioned for a better fit or removed if complications occur.

The system is delivered endovascularly via an 18F introducer sheath. Apparently, during the trial, all patients were successfully treated via a transfemoral approach using Direct Flow Delivery System. The primary endpoin - freedom from all-cause mortality from procedure to 30 days - was met at 97%. Freedom from all cause cardiovascular mortality at 30 days was 100%. they say that the valve resulted in 97% mild or less aortic regurgitation.

Source: Medgadget.com, 02 November 2012.

Read the full article here.

Study Confirms the Socioeconomic Value of Medical Devices

Tue, 06 Nov 2012 14:59:26 GMT

Healio reports how researchers in a recent issue of Orthopedic Research and Review have concluded that medical devices, such as hip protectors and total joint arthroplasty implants, are cost-effective and significantly improve patients’ lives. They say that the devices enable people to quickly return to an active, independent lifestyle and lower the risk of future fracture.

Apparently, according to the European Health Technology Institute for Socio-Economic Research (EHTI), a review of 33 studies published between 1996 and 2008 showed that hip protectors reduced the mean fracture risk in patients by 4%. Total hip arthroplasty increased clinical scores in patients by 25-35 points and total knee arthroplasty increased clinical scores by 15-56 points. Total joint procedures brought an average 2.01 quality-adjusted life-years, according to the abstract.

The research was said to have demonstrated that the devices represented good value for money, and, in case of hip protectors, even saved on costs.

Source: healio.com, 5 November 2012

Read the full, original article here.

CE Mark for Drug-Eluting Stent

Thu, 01 Nov 2012 10:54:09 GMT

Massdevice reports that medical device manufacturer, Boston Scientific, has announced that it has won CE Mark approval for its Synergy drug-eluting stent. The device has a bioabsorbable coating which is designed to deliver everolimus over the 3 months that it takes the drug to dissolve. The company plans to release the device in Europe, on a limited basis, then elsewhere by early 2013 followed by a wider launch in 2014.

Apparently, the CE Mark application was based on Boston Scientific's 'Evolve trial' which compared the Synergy device with the company's Promus Element DES. The Synergy device coating is applied only to the exterior of the stent whereas the Promus Element's coating is applied to both the interior and exterior.

The article says that the 291 patient Evolve study compared 2 versions of the Synergy device with the Promus Element. One of the Synergy arms received stents coated with a half-dose of everolimus, the other with a full dose. The results from the study were published in the April issue of the Journal of the American College of Cardiology. They showed that the Synergy stent met its primary safety endpoints (target lesion failure at 30 days) and its efficacy endpoints (in-stent late loss at 6 months). Boston Scientific said the Synergy device posted a target lesion revascularization rate of 1.1% and a 0% rate of stent thrombosis after a year.

Source: Massdevice, 31 October 2012

Read the full article here.

Europe too Slow to Protect Patients?

Thu, 01 Nov 2012 10:20:33 GMT

The BBC reports on how the UK's Science and Technology Select Committee has warned that the CC European Commission is not acting quickly enough to protect patients from potential harm from medical implants such as hip replacement joints. They call for the process to be speeded-up.

The Committee has rallied for transparency and accountability whereby both patients and doctors know where implants have come from, whether a device has been rejected by any other regulatory bodies and details about the safety testing. They recommend that for all medical implants that are currently in use, existing data should be published immediately and that doctors should report any faulty products.

Apparently, the EC is revising the process but changes aren't likely to take effect until at least 2015.

Source: Smitha Mundasad, BBC News, 01 November 2012

Read the full article here.

CE Mark Given for Suite of Ventricular Partitioning Implants

Tue, 30 Oct 2012 12:24:40 GMT

Massdevice reports on how medical device manufacturer CardioKinetix has achieved the CE Mark for the full suite of its Parachute ventricular partitioning devices, including 8 sizes designed to provide support to weakened heart muscles. The company is planning a European launch, in 2013.

Apparently, the Parachute device has been implanted in around 90 patients. The Parachute implant is inserted into the heart via a catheter threaded through the femoral artery. Once inside, the device springs open and attaches to the walls of the heart to provide support for patients whose left ventricle was left enlarged after a heart attack.

The article says that clinical results for the Parachute showed 3 year safety and sustained low clinical events on ischemic heart failure patients.

Source: Massdevice, 25 October 2012

Read the full, original article here.

FDA Approves Spine Access Plate System

Mon, 29 Oct 2012 10:27:26 GMT

Massdevice reports on FDA approval for SpineSmith's VisuALIF device which is designed to help surgeons with difficult anatomical angles during surgical procedures. Apparently, the device may provide surgeons with an option for in-situ graft delivery and managing challenging anatomical angles during surgery.

They say that the manufacturer claims that the VisuALIF system offers alternatives to traditional devices in the marketplace.

Source: Massdevice.com, 25 October 2012

Read the original article here.

New Treatment Option for Patients at Risk of Sudden Cardiac Arrest

Mon, 29 Oct 2012 09:55:14 GMT

The Scaramento Bee reports on the FDA's approval of what they describe as 'the world's first subcutaneous implantable defibrillator' providing a new treatment option for patients who are at risk of sudden cardiac arrest.

The S-ICD System, manufactured by Boston Scientific, has two main components. One is a pulse generator which powers the system, monitors heart activity and delivers a shock, if required. The second main component is an electrode that enables the device to sense the heart rhythm and deliver shocks when necessary. Both are implanted just under the skin, providing protection without touching the heart and reliable defibrillation without transvenous wires.

The Bluhm Cardiovascular Institute is one of the first ten places to implant in the US.

Source: The Sacramento Bee (www.sacbee.com), 25 October 2012

Read the original article here.

Expanded CE Mark Enables Label Update for Coronary Stents

Fri, 26 Oct 2012 13:57:54 GMT

Mass Device reports that medical device manufacturer, Boston Scientific, has gained an expanded CE Mark which will enable the company to update the label directions for the use of its Promus Element Plus coronary stents. They say that the new labels can also include clinical guidelines for 3 month dual anti-platelet drug therapy (DAPT), for specific patients.

According to the manufacturer, they will introduce the new labelling in CE Mark countries.

Apparently, Boston Scientific also announced that its next-generation Synergy stent may address some of the issues associated with durable stent polymers, such as those on Promus Element and Promus Plus, by using a bioresorbable polymer that dissolves within 3 months of implantation.

Source: Mass Device, 24 October 2012

Read the original article here.

Orthopaedic Pain Relieving System Gains CE Mark

Wed, 24 Oct 2012 10:19:22 GMT

Medical Device Business Review reports that device manufacturer, Alpha Orthopaedics' AT3 pain relieving system has achieved the CE mark. The device is designed for relieving pain associated with tendinosis and fasciosis.

They say that by using non-invasive ReleF technology, the device delivers RF energy and by its cooling effect generates temperature that can trigger heat-shock proteins and other mediators of the wound healing response. According to he manufacturer, both are needed to induce the reparatory process which is believed to relieve the pain and enables the damaged structures to return to regain their normal state.

Alpha Orthopaedics claim that the sustem is superior to Platelet Rich Plasma (PRP) which was demonstrated in a side-by-side study over 18 months of follow-up.

Source: Medical Device Business Review, 19 October 2012

Read the original article here.

Largest TAVI Device Study Shows Positive Patient Outcomes

Tue, 23 Oct 2012 11:30:43 GMT

Reuters reports on a press release from Medtronic which announces new findings from the medical device manufacturer's CoreValve ADVANCE Study for 1-year survival and health-related quality of life. The findings, presented this week at Transcatheter Cardiovascular Therapeutics Meeting 2012 in Miami, indicated high survival rates and improved quality of life for patients.

The study revealed a 1 year survival at 82.1% and 1year cardiovascular survival at 88.2%. Health-related quality of life (HRQoL) measures for patients in the ADVANCE Study improved significantly at 1 and 6 months, compared with their status prior to receiving the Medtronic CoreValve System. They say that the ADVANCE study represents the largest, most rigorously collected evaluation of HRQoL findings published on transcatheter aortic valve implantation (TAVI).

Apparently, in the study, even the highest risk patients experienced significant improvements in HRQoL after TAVI. The article goes on to say that the ADVANCE study is one of the largest multicenter TAVI trials to date, with 996 patients consecutively treated at 44 experienced TAVI centers in 12 countries.

The CoreValve System is currently limited to investigational use in the United States.

Source: Reuters, 22 October 2012

Read the original article here.

FDA Approves Expanded Use for Heart Valve

Tue, 23 Oct 2012 11:52:25 GMT

The Los Angeles Times reports that Edwards Lifesciences has gained FDA clearance to expand use of the company's transcatheter heart valve, as an alternative to open-heart surgery.

They say that the device is meant to treat severe aortic stenosis and that the device label states that the opinion of a heart surgeon should be taken into account when considering whether Sapien is the right choice for the patient.

Device manufacturer, Medtronic, is now testing a similar device, CoreValve, and the company expects to receive FDA approval in 2014 for porocedures where patients unsuitable for surgery.

Source: Los Angeles Times, 23 October 2012

Read the original article here.

'Bespoke' Implants to Replicate Natural Joint Shape

Thu, 18 Oct 2012 09:59:19 GMT

Medgadget reports that medical device manufacturer ConforMIS has announced the commercial availability of its next generation iTotal G2 Knee Replacement System. Medgadget previously reported on the ConforMIS’ iTotal CR knee replacement system which they describe as 'the only patient-specific total knee replacement available on the market today'.

They say that the iTotal G2 incorporates improvements based on surgeon feedback on the implants, instrumentation and patient specific planning guides.

Apparently, ConforMIS’ iFit technology maps a diseased joint using CT imaging to define the natural shape of the femoral and tibial components and enable the production of 'bespoke' implants.

Source: medgadget, 17 October 2012

Read the original article here.

Heart Pump to Benefit Previously 'Inoperable' Patients

Tue, 16 Oct 2012 11:04:17 GMT

NBCsandiego.com reports that one of the first patients on the West Coast (US) has benefited from the use of the Impella heart pump during a medical procedure. The device makes available a miniminally invasive technique for previously inoperable patients and is mooted as the newest version of the world’s smallest heart pump.

The US patient underwent heart bypass surgery 11 years ago, 3 heart attacks and the amputation of a leg and the procedure was conducted by cardiologists at Scripps Green in La Jolla. The Impella heart pump received FDA clearance last month when the device was approved to maintain blood flow during surgery. Apparently, the properties of the device mean that high-risk patients with blocked arteries can now undergo arterial repair without major surgery.

The article says that the Impella pump is inserted via catheter through a tiny incision in the patient's femoral artery and is then moved into position so that it will pump large quantities of blood through the body thereby taking over the pumping action of the patient’s heart.

The device is designed to pump up to 4 litres of blood per minute through a patient's circulatory system. The catheter-delivered pump allows the heart to rest while repairs are made to damaged arteries. Previous versions of the heart pump provided about 2.5 litres of blood-flow per minute.

Source: Christine Haas, nbcsandiego.com, 15 Oct 2012

Read the original article here.

Spider Silk May Benefit Medical Devices

Mon, 15 Oct 2012 12:41:29 GMT

Medgaget reports on how spider silk has been discovered to be an excellent light conduit, nearly approaching fiber optics, thus opening up its use for medical devices. Teams from CNRS Institut de Physiques de Rennes in France and Tufts University will present their research into the light properties of silk, at next week’s Optical Society’s (OSA) Annual Meeting, Frontiers in Optics.

Apparently, through being biocompatible, biodegradable, strong and having light properties, silk has potential to be used as a component within implantable devices. The Tufts team is working on creating a material out of silk that mimics plastic whilst retaining its light properties. The French team, meanwhile, is working on utilising spider silk as a material for photonic chips which could provide a new way for developing implantable light sensors that monitor blood, tissue and the body’s health.

Source: medgadget.com, 12 Oct 2012

Read the original article here.

FDA Approves Angiographic Catheter Line

Mon, 15 Oct 2012 12:54:03 GMT

Massdevice reports that Surefire Medical has gained FDA clearance for a suite of angiographic catheters which have different curve styles to help interventional radiologists access patient anatomies during infusion procedures. Apparently, the devices provide optimal diagnostic imaging and detail.

They say that the devices will be launched in the US, later this year.

Source: massdevice.com, 10 Oct 2012

Read the original article here.

New Venous Self-Expanding Stent Available for Canada

Tue, 09 Oct 2012 12:36:19 GMT

Financialpost.com reports that following Health Canada approval, Cook Medical's Zilver Vena Venous Self-Expanding Stent is available to physicians across Canada. The news was announced at the 2012 Annual Meeting of the Canadian Society for Vascular Surgery.

The article says that the medical device is designed to restore blood flow in obstructed iliofemoral veins. This condition can arise for various reasons, including post-thrombotic syndrome in deep vein thrombosis (DVT) patients.

Built on Cook’s established line of Zilver stents, the Zilver Vena stent is described as providing flexibility, consistent radial force and continuous stent-to-vein wall apposition from end to end. Zilver Vena is currently available in 14 and 16 mm diameters and 60, 100 and 140 mm lengths to enable precise placement and is compatible with 7 Fr sheaths and 9 Fr guiding catheters.

Source: financialpost.com, 05 Oct 2012

Read the original article here.

Study Indicates a 100% Success Rate for Renal Denervation System

Mon, 08 Oct 2012 12:34:41 GMT

According to a press release from Medtronic, a feasibility study for the medical device manufacturer's next generation investigational multi-electroderenal denervation system has shown a 100% success rate in patients with treatment-resistant hypertension.

They say that Medtronic successfully completed the first phase of the feasibility study of the device which features a simultaneously firing multi-electrode catheter and advanced radio-frequency generator. 9 patients were treated with a 100% acute success rate in accessing the vessels and delivering therapy.

The investigational next-generation Symplicity system is not commercially available anywhere in the world. According to Medtronic, the single-electrode Symplicity renal denervation systemhas been used for 5 years to treat more than 5,000 patients with treatment-resistant hypertension worldwide. The single-electrode Symplicity system’s catheter and proprietary generator and algorithms were developed through years of clinical experience to enhance the safety and effectiveness of the renal denervation procedure. The device is only available in the United States for investigational use.

Medtronic continues that the next-generation system will feature a new 4 electrode catheter that delivers RF energy simultaneously and is designed to significantly reduce ablation time during renal denervation procedures. The new catheter will be 6 Fr compatible, highly conformable and have a non-occluding design for ease of deliverability and consistency of RF energy application, while also enabling the treatment of a wide range of renal anatomies.

Apparently, the device incorporates a new generator with an improved user interface. The new generator will leverage the benefits of Medtronic’s proven and proprietary Symplicit treatment algorithm and will be compatible with both the single-electrode Symplicity catheter and the next-generation multi-electrode catheter.

Source: Medtronic Press Release, 03 October 2012

Read a report in Reuters here.

WhichMedicalDevice hosts details on Medtronic's Simplicity Catheter System (the device was manufactured by Ardian until January 2011, when the company was taken over by Medtronic) which delivers radiofrequency (RF) energy from within the renal artery to block conduction in the surrounding renal nerves. It thereby counteracts chronic activation of the sympathetic nervous system. According to the manufacturer, in addition to blood pressure reduction, this treatment has shown promising results for chronic kidney disease, insulin resistance and heart failure. Apparently, treatment is performed in the catheterisation laboratory using interventional techniques similar to those used in other endovascular procedures and does not involve a permanent implant.

An excellent overview of renal sympathetic denervation can be found in an editorial article added to our web site, earlier this year: Renal Sympathetic Denervation: rationale, evidence and future implications.

The site also hosts 2 videos of great interest: the first, which can be accessed beneath the device description, is a short video by Ardian/Medtronic explaining the mechanism of treatment; and the second is a video of a live procedure using the device.

8 New Orthopaedic and Spine Device Launches

Fri, 05 Oct 2012 12:52:34 GMT

Beckersorthopedicandspine.com lists a range of 8 new orthopaedic and spine devices that are available in the marketplace:

Arrowhead Medical recently launched its next generation Arrow-Lok Digital Fusion System to treat hammertoe.

Biomet launched its Comprehensive Nano shoulder device in Europe, which is designed to reproduce a native humeral head version and inclination.

Corentec America launched the Lospa Knee System, which offers an atomically featured shape for the cruciate retaining and posterior stabilized knee with a single system.

DePuy Mitek launched its ENDURANCE Hi Solutions, a new system of instruments and devices for hip arthroscop.

K2M launched the SERENGETI Complex Spine Minimally Invasive Retractor System for complex reduction, controlled manipulation and above-skin compression and distraction with direct visualization.

Safe Orthopaedics launched SteriSpine PS pedicle screw system with a full-featured lumbar fixation system in a sterile, traceable and single-use format.

Smith & Nephew launched its LEGION HK Hinge Knee implant designed to match the knee's anatomy and restore normal function, with a seamless transition from a constrained revision implant to hinged assembly.

Spinal Elements announced plans to launch its Hero Allograft that consists of various configurations of human allograft tissue used during fusion procedures.

See the original article here.

Source: Laura Miller, beckersorthopedicandspine.com, 02 October 2012

FDA Approves Wire-Free Pacemaker

Thu, 04 Oct 2012 09:52:06 GMT

Massdevice reports that Boston Scientific and newly acquired Cameron Health have received FDA approval for the world's only commercially available lead-free implantable cardioverter defibrillator, the S-ICD. Implanted just under the skin, they say that the S-UCD is the only device of its kind that does not require wires threaded into the heart in order to provide therapy.

The S-ICD system won CE Mark approval in 2009 and to date, more than 1,400 devices have been implanted in patients around the world, according to a press release from Boston Scientific. The manufacturer expects to begin a phased launch of the S-ICD system that will expand over the time.

Source: Massdevice.com, 03 October 2012

Read the original article here.

Promising Results from Prostate Device Study

Wed, 03 Oct 2012 11:31:20 GMT

Masshightech.com reports on a study about a device designed for use in the treatment of prostate cancer which states that it can discriminate between cancer and healthy tissue with “a very high degree of accuracy.”

Apparently, the MarginProbe System is Dune Medical Devices's first commercial product and it is now approved and available in Europe for use in detecting diseased tissue in breast cancer patients. A prototype of the device for prostate cancer is based on the same technology but shaped differently than the breast cancer device. It is now in feasibility studies.

The study published in Nature.com involved more than 15,000 measurements in 49 patients. The abstract from the study reported the device's ability to discriminate between malignant and nonmalignant cells with a sensitivity and specificity of between 68.4% and 93.6% depending on the size of the cancer. The abstract of the Nature.com article concludes, "First results from a radio-frequency near-field spectroscopy sensor look promising for differentiation between cancer and benign prostate tissue."

Source: By Don Seiffert, masshightech.com, 17 September 2012

Read the original article here.

New Data and Lancet Analysis Trigger a Further Warning on Hip Resurfacing

Tue, 02 Oct 2012 10:48:14 GMT

The BBC reports on a warning from doctors that due to the high failure rate of hip resurfacing, it should, in most cases, not be ised as an alternative to hip replacment. The advice comes as the Lancet issues its findings based on an analyisis of data from the National Joint Registry for England and Wales (read the Lancet summary here).

Hip resurfacing - where the damaged bone is capped rather than replaced - is often recommended for younger, active patients who will need more surgery as the joint continues to wear. Apparently, the UK's MHRA will look at the Lancet findings. They have already advised annual checks for people with large head metal-on-metal full hip replacements due to safety concerns. It is thought tiny pieces of metal can break off and leak into the blood.

The current study did not look at the safety of the metal resurfacing implants, although the researchers say there could be the same theoretical safety risk as with metal-on-metal hips. Instead it looked at failure rates with metal-on-metal resurfacing - where the socket and ball of the hip bone has a metal surface applied to it rather than being totally replaced.

The BBC article says that about 7 in every 100 hip patients go for resurfacing rather than a full hip replacement, although the rate has been decreasing in recent years. Some 32,000 people in England and Wales had this type of surgery between April 2003 and September 2011. The Bristol University team looked at the National Joint Registry data to see how many of these implants failed in the first seven years after surgery and how they compared with conventional full or "total" hip replacements.

In women, the resurfacing implants failed more quickly than total hip replacements. The five-year failure rate was about 5% on average compared with less than 2% for total hip replacement. The failure rate in women was so high - up to five times greater - that the researchers believe resurfacing implants should never be used in women. Similarly, they should not be recommended to men - the only exception is men with particularly large hip bones who appear to fare as well with resurfacing as with a total hip replacement, say the researchers.

The story includes a positive impact of hip resurfacing in that it is less invasive than a total hip replacement and leaves a patient with a greater range of movement after surgery. Plus, new, stronger materials for prosthetics are being developed that will allow longer wear and better joint mobility.

Source: BBC, 02 October 2012

Read the BBC story here.

Diabetic-Friendly Drug-Eluting Stent System to Debut in India

Tue, 02 Oct 2012 16:21:27 GMT

Massdevice reports that Medtronic's Resolute Integrity stent is to make its market debut in India, following FDA clearance, in February.

They say that the device is the first of its kind approved for use in patients with diabetes in addition to coronary artery disease (CAD). With India hosting the 2nd largest population of diabetics in the world, the launch may be an important one for patients in the country as well as for the manufacturer's ongoing commitment to expanding the company's reach in emerging markets.

According to the Medtronic, CAD patients with diabetes represent a difficult-to-treat population, as they often have smaller and more complex arteries, longer lesions and a higher rate of treatment failures. Apparently, because of complications arising from the co-morbidity, many patients are treated with open heart surgery, a more invasive option that requires extended hospital care and recovery time.

Although percutaneous interventions are often used for diabetic patients with CAD, no drug-eluting stent had previously been approved specifically for that population.

Source: Massdevice, 28 September 2012

Read the full article here.

'Heart-Zapping' Heart Defibrillator for the US

Mon, 01 Oct 2012 15:40:13 GMT

The Washington Times reports on a 'heart-zapping' implant from Boston Scientific that claims to be the first-of-a kind that does not directly touch the heart.

The article says that implantable defibrillators use thin wires to send electrical signals that disrupt dangerous heart rhythms. Surgeons have traditionally connected the wires to the heart through a blood vessel in the upper chest. Apparently, the new device uses wires that sit just below the skin’s surface and do not need to be threaded through the heart’s blood vessels.

Source: The Washington Times, 28 September 2012

Read the original article here.

A further story appears in the Chicago Tribune.

FDA Approves Ground Breaking Endovascular Aortic Repair Devices

Mon, 01 Oct 2012 14:44:28 GMT

Healthcanal.com reports on 2 devices, recently approaved by the FDA apparently offer more life-saving options to patients experiencing aortic disease or injury. Both devices were tested in clinical trials at the University of North Carolina School of Medicine have been approved by the FDA.

They say that the first device, the RELAY Thoracic Stent Graft with PLUS Delivery System manufactured by Bolton Medical, is designed to treat thoracic aortic aneurysms (the 13th leading cause of death in the US) occuring in the aorta as it passes through the chest. Apparently, the device offers a range of sizes and ease of use to help to expand the use of the minimally-invasive treatment to a broader segment of patients. The US study included more than 120 endovascular patients at 30 hospitals across the country.

Healthcanal describes the second device, the Conformable TAG Thoracic Endoprosthesis, manufactured by Gore Medical as used for endovascular repair of a traumatic thoracic aortic transection. They say that over 8,000 people each year (US) experience a transection of their aorta, involving profuse bleeding and high mortality rate - most often caused by a severe injury to the chest as a result of a motor vehicle accident, crushing of the chest, or a high fall.

Apparently, prior to the successful clinical tria, the only treatment option for traumatic thoracic aortic transection was open surgical repair; the minimally-invasive endovascular repair of traumatic thoracic aortic transection reduces recovery time and pain for patients who have experienced this type of transection.

Source: healthcanal.com, 27 September 2012

Read the full article here.

For a further report on this story, click here.

US Go-Ahead for Percutaneous Transluminal Coronary Angioplasty Balloon Dilation Catheters

Mon, 01 Oct 2012 15:03:07 GMT

Massdevice reports that Boston Scientific has won FDA clearance for the Emerge percutaneous transluminal coronary angioplasty balloon dilation catheters in treatment of coronary artery disease, he leading cause of death in the US. They say that the devices, used during angioplasty and stenting procedures, help open clogged arteries that, left untreated, could lead to heart attack.

The company has already begun marketing the device, offering both Monorail and Over-The-Wire balloon catheter options, according to a company press release.

Earlier this year, the Natick won CE Mark approval in the EU for the Emerge PTCA line and began commercialisation, immediately. Apparently, the catheters are also available in a range of sizes from 1.2mm up to 4mm, with balloon lengths ranging from 8mm up to 30mm.

Source: Massdevice, 27 September 2012.

Read the full article here.

Robotic Snake Could Search for and Destroy Tumours

Thu, 27 Sep 2012 09:50:39 GMT

An article hosted on iod.com reports that engineers from OC Robotics in Bristol, UK, have taken clinicians a step closer to using a Prometheus-style med pod. At the recently concluded International Conference on Oncological Engineering, developers unveiled a prototype medical robot to help surgeons reach deep inside patients, without the need for open surgery. Apparently, once the device is ready for prime time, a surgeon could use it to locate and eradicate tumours.

The articles goes on to say that developers claim that the mecha-snake will result in minimally invasive procedures. Once fully developed, the snake will enter the body via a local incision or through a bodily orifice. This will allow surgeons to look and feel inside the body. The device will also be equipped with a camera and other sensitive equipment allowing surgeons to track and guide its progress.

Source: George Dvorsky, io9.com (original source - BBC).

Read the full article here.

Aortic Valve Wins CE Mark

Thu, 27 Sep 2012 10:33:03 GMT

MDBR reports that Medtronic's new self-expanding 23mm CoreValve Evolute transcatheter aortic valve implantation (TAVI) system has achieved the CE Mark.

They say that the device allows low-profile 18Fr delivery catheter via transfemoral, subclavian and direct aortic access and promotes the sealing between the prosthetic valve and the native valve. Apparently, the system has been successfully implanted in tens of thousands of patient, worldwide.

In addition to valve size of 23mm, Medtronic is offering 26mm, 29mm and 31mm sizes to treat various TAVI patient valve sizes.

Source: MDBR, 27 September 2012

Read the full article here.

A further article appears on Reuters.com.

CE Mark Reduces Recipient Age for Bioprosthetic Heart Valve

Tue, 25 Sep 2012 10:54:25 GMT

Massdevice reports that the Sorin Group has won CE Mark approval to extend the use of its Perceval bioprosthetic heart valve and introduce a new suite of implantation accessories.

The Perceval valve originally won a CE Mark last year but was limited to use in patients aged 75 or older. The new indication now lowers the age to 65 for patients with aortic valve stenosis or steno-insufficiency.

Source: Massdevice.com, 18 September 2012

Read the full article here.

FDA Approval for Aortic Securement System

Mon, 24 Sep 2012 10:40:11 GMT

News-medical.net reports that the FDA has approved a thoracic-length HeliFXTM Aortic Securement System, from medical device manufacturer, Aptus Endosystems. They say that it is similar to the original HeliFX system that was cleared in November 2011 and designed for treating abdominal aortic aneurysms.

The new system consists of a longer delivery device with additional tip configurations to bring the innovative helical EndoAnchorTM technology to the treatment of thoracic aortic aneurysms, enlarged and weakened section of the aorta, the main artery carrying blood from the heart.

Apparently, the implantable EndoAnchor enables independent endograft fixation and is designed to replicate the sealing and fixation of hand suturing performed during open surgical repair of aortic aneurysms. It can be used during de novo (initial) TEVAR procedures to enhance an endograft's inherent fixation and sealing mechanisms. Plus, the EndoAnchors can be used to repair endovascular grafts that have migrated away from the implant site and have developed endoleaks or are at risk of developing these complications.

Source: News-medical.net, 19 September 2012

Read the full article here.

FDA Gives Green Light on Post Approval Clinical Study of Surgical Ablation System

Mon, 24 Sep 2012 10:16:26 GMT

Massdevice reports that the FDA has given the go-ahead on AtriCure's post-approval clinical study of its Synergy radiofrequency ablation system in treatment of non-paroxysmal atrial fibrillation, a chronic and hard-to-treat heart disease.

The new 3-year, 350-patient ABLATE study follows the West Chester, Ohio-based device maker's December 2011 FDA win for the Synergy ablation system, indicated for treatment of AF during open-heart surgery. Previous Synergy studies found that 84% of patients were free from AF at 6 month following treatment, and 75% remained AF-free at 22 months.

According to the manufacturer, the device was the 1st surgical ablation system approved by the FDA for treating AF and the 1st approved for treating persistent and long-standing persistent AF. The FDA cleared the Synergy device for cardiac ablation during concomitant open-heart surgical procedures.

Source: Massdevice 17 September 2012

Read the full article here.

FDA Approves Anterior Cervical Plate System

Sun, 23 Sep 2012 10:26:33 GMT

Medgadget reports on a press release from device manufacturer, Spinal USA, who have announced that their Slimplicity Solo anterior cervical plate system has been cleared by the FDA.

The device is designed for fixation of the C2–C7 vertebrae to manage trauma, degenerative disc disease, deformity, pseudarthrosis, failed previous fusion, spondylolisthesis and spinal stenosis.

According to the manufacturer, the titanium device is one of the slimmest profile plates available in the market.

Apparently, on evaluating the system, Dr. Henry E. Aryan, a board certified neurosurgeon and Associate Professor at the University of California, San Francisco, commented, “The Slimplicity Solo is well designed for use in 1- and 2-level ACDFs. Its narrow footprint and low profile are dimensioned to reduce strap muscle dissection and dysphagia. Its single, larger diameter screw-plate construct enables stability and facilitates quicker implantation. The system design lends itself for use in women, in thinner patients, or adjacent to an existing construct.”

Source: Brian Klein, Medgadget, 18 Sept 2012

Read the full article here.

FDA Clearance for Catheter System

Fri, 21 Sep 2012 11:19:45 GMT

Plasticsnews.com reports on a new IV catheter system designed to minimise the risk of needle-stick injuries and occupational exposure to blood which has received market clearance from the FDA.

They say that the NovaCath Secure IV Catheter System, manufactured by Tangent Medical Technologies, integrates a series of next-generation technologies designed to address catheter stabilisation, healthcare worker safety, tubing management and patient comfort.

Apparently, TMT claim that the NovaCath’s integrated advanced catheter stabilisation technology can eliminate an external ‘j-loop’ based on its redirect of the fluid path internal to the device.

Source: Mike Verespej, plasticsnews.com, 17 September 2012

Read the full article here.

Promising Results for Aneurysm Device

Thu, 20 Sep 2012 10:52:37 GMT

Masshightech reports that medical device developer, Codman & Shutlef has seen positive results for its Vascular Reconstruction Device (VRD), a self-expanding stent used in patients with wide neck saccular aneurysms.

They say that data published in Neurosurgery showed 81% of patients had 90% or higher aneurysm closure after 21 months and only 8.3% required retreatment after stent-assisted coil embolization with Codman’s VRD. The registry included data of 229 patients from 9 neurointerventional centers including the University of Florida, Albany Medical Center Hospital, Capital Health System, University of Texas Southwestern and Mayo Clinic.

32 of the patients had ruptured aneurysms. On average, patients were 57 years old at the time of treatment and had a 9.2 millimeter aneurysm. Apparently, the data also showed that 90% of patients had modified Rankin Scale scores of 2 or less. The mRS score, measuring the degree of disability in daily activities, showed no significant disabilities nearly 2 years after treatment with the device.

Source: By Patricia Resende, masshightech.com, 17 September 2012

Read the full article here.

UK Calls for a Close Watch on Riata Patients

Thu, 20 Sep 2012 11:07:44 GMT

Massdevice reports that UK health and regulatory agencies have been keeping a close eye on St. Jude and its Riata leads since late last year, when the company had to remove the devices from the US following an FDA Class I recall directive. Apparently, reports showed that the devices may be prone to internal short circuits that were more rare than the incidence of exposed wires but potentially more dangerous.

St. Jude also pulled its QuickSite and QuickFlex left-ventricular leads in the US after finding 39 confirmed cases of exposed wires.

Apparently, the UK's alert calls for physicians to keep a close watch on Riata patients, conduct regular testing to determine the integrity of the leads and consult with patients about whether or not to replace defective wires or take a proactive approach against intact leads, perhaps during a defibrillator box replacement procedure.

The MHRA urged physicians to make sure that, should a patient decide to keep Riata or Riata ST leads at the time of box replacement, that any future devices contain remote/advanced monitoring capabilities.

Source: Massdevice, 17 September 2012

Read the full article here.

Low Cost Device Design Makes Ultrasound Imaging Affordable Worldwide

Wed, 19 Sep 2012 09:45:58 GMT

Newcastle University in the UK has announced the development of a low cost ultrasound scanner. The hand-held USB device, created by Jeff Neasham and Research Associate Dave Graham at the University, is around the size of a computer mouse and works in a similar way to existing ultrasound scanners, using pulses of high frequency sound to build up a picture of an unborn child on a computer screen. However, unlike the technology used in most hospitals across the UK costing anywhere from £20,000-£100,000, the scanner can be manufactured for as little as £30-40.

Tested by experts in the Regional Medical Physics Department at the Freeman Hospital, part of the Newcastle upon Tyne Hospitals NHS Foundation Trust (UK), the scanner produces an output power that is 10-100 times lower than conventional hospital ultrasounds. They say that it is hoped the device will be used to provide medical teams working in the world’s poorest nations with basic, antenatal information that could save the lives of hundreds of thousands of women and children.

According to the University, Mr Neasham said the original aim had been to make something portable and easy to use that would be affordable in developing countries as well as for some applications in the UK where ultrasound is still considered cost prohibitive. An expert in underwater sonar technology, he has developed systems for imaging the seabed – looking for ship wrecks or specific geographical features – as well as underwater communications and tracking systems. Drawing on his expertise in sonar signal processing, the design keeps components and hardware costs to an absolute minimum, and works by manually sweeping a transducer over the skin while a focussed image is formed by the PC software.

Apparently, the scanner requires nothing more than a computer with a USB port in order to work.

The University is seeking collaborative and/or licence opportunities with a suitable industrial partner who can take the next steps of commercialising the technology. More information about the product is available here.

Source: Newcastle University (UK), 14 August 2012

Read the press release here.

New Self-Expanding Stent & Matching Balloon Catheter Launched

Wed, 19 Sep 2012 10:38:56 GMT

Medgadget reports on a new self-expanding stent and matching balloon catheter from medical device manufacturer, BIOTRONIK. The Pulsar-35 is based on the Pulsar stent that provides high multi-axis flexibility and can be positioned using one handed operation by the surgeon.

They say that the Pulsar-35 features a triaxial delivery system designed to provide precise implantation accuracy and the system benefits from the same stent design as the Pulsar-18—including features such as high multiaxis flexibility and optimised radial force specifically designed for the challenges of SFA stenting. The stENT is available in lengths from 30 mm to 200 mm and diameters of 5 mm to 7 mm to provide an additional treatment option.

The Passeo-14 balloon catheter is a dedicated 0.014″ infrapopliteal percutaneous transluminal angioplasty (PTA) catheter. Apparently, it was developed in collaboration with infrapopliteal experts and the device features are designed to address weaknesses common to infrapopliteal PTA catheters. Key features include a stiffened proximal catheter shaft and hydrophilic coating to assist push transmission and crossability and a balloon-diameter-specific distal shaft length for optimised flexibility in tortuous pedal anatomy. The device is available in balloon lengths of up to 220 mm. The article provides that the device may shorten procedure times and could reduce the need for multiple inflations.

Source: Gene Ostrovsky, medgadget.com, 17 September 2012

Read the full article here

New WEEE Directive for Medical Device Recycling

Tue, 18 Sep 2012 12:58:36 GMT

There is an interesting article at biomedEM.com which focuses on how Waste Electronic and Electrical Equipment (WEEE) legislation is tightening in respect of medical devices.

They report that effective from 13th August 2012, within the EU, medical devices are subject to a recovery target of 70% and a recycling target of 50%; from 15th August 2015: Medical Devices are subject to recovery target of 75% and a recycling target of 55%; from 15th August 2015: Medical Devices (falling under category 4: Large equipments) have a recovery target of 85% and a recycling target of 80%. Medical devices (falling under category 5: Small equipments) are subject to a recovery target of 75% and a recycling target of 55%.

Apparently, non-EU manufacturers appointing a European Authorized Representativeunder the Medical Device Directives & CE marking requirements should invest in their product’s “end of life” EU conformity and require their EU importers & distributors to provide them with the evidence of registration, reporting and the detailed take-back process prior to affixing the WEEE symbol onto their packaging.

Source: biomedME.com, 13 September 2012

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FDA Clearance for Blood-Drawable, Power Injectable Catheter

Mon, 17 Sep 2012 11:38:35 GMT

Dotmed news.com reports that Access Scientific has received FDA Clearance for the 4Fr Nanopuncture POWERWAND which they describe as a newly improved peripheral IV catheter that is blood-drawable, power-injectable and can deliver therapy for the entire length of a patient's hospital stay.

The article describes the catheter as light weight and designed to provide smoother handling and greater ease of insertion. The power-injectable catheter is inserted using the proprietary Accelerated Seldinger Technique.

Apparently, the POWERWAND can be used to administer fluids and medications and for withdrawing blood for diagnostic tests. The article goes on to say that the device is the first and only power-injectable peripheral IV (PIV) catheter capable of delivering continuous IV therapy for theduration for a patient's sta, up to a maximum of 29 days. It is also designed to be an integral part of any program to reduce central-line associated bloodstream infections (CLABSI).

According to dotmednews, in addition to allowing consistent blood draws, the catheter has a flow rate of 130 mL per minute which makes it the fastest-flowing peripheral line of its size.

Source: www.dotmednews.com, 13 September 2012

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New Cancer Detection Device May Reduce Additional Breast Surgery Operations

Mon, 17 Sep 2012 12:15:45 GMT

Cancernetwork.com reports on a new device called MarginProbe, manufactured by Dune Medical Devices which may soon be available to help surgeons determine the minimal amount of tissue to be removed during a lumpectomy. The tool is designed to detect cancer tissue margins during a surgical procedure which could reduce the need for any subsequent operations.

They say that a large, prospective trial presented at the American Society of Clinical Oncology Breast Cancer Symposium, San Francisco, shows that when the MarginProbe device is used during surgery, re-excision rates are significantly lower than when no device was used.

They go on to say that women with invasive carcinomas or DCIS who do not have a high risk of recurrence undergo a lumpectomy followed by radiation therapy rather than a mastectomy. Currently, a pathology review for negative or positive margins is done postsurgery. Re-excision is necessary if positive margins—cancer cells left in the margin of the excised tissue—are found. Typically between 30% and 60% of women need to undergo a second surgery to remove the positive margins.

The results of this trial suggest that margin analysis can be readily done with the MarginProbe device during the initial lumpectomy to obtain negative margins without the need for secondary surgery.

596 patients with either DCIS or invasive carcinoma undergoing a lumpectomy were randomised to analysis with the device or no analysis. The device was used on the main lumpectomy specimen and if positive margins were detected, patients were further resected while in the operating room. The study was conducted internationally at 21 cm.

Apparently, the decrease in the frequency of re-excision between the experimental device and control arms was statistically significant. Of the 161 women in the study who had only DCIS, 13% of those in the device group needed re-excision compared to 37% of those in the control arm (P = .004). For the 334 women with both DCIS and invasive carcinoma, 17% of those in the device arm needed re-excision compared to 33% in the control arm (P < .001). The study found the total tissue, including initial lumpectomy and any subsequent resectioning in patients was the same in both the experimental and control groups.

The article concludes that more studies are likely to be needed to demonstrate the utility of MarginProbe and that the FDA recently gave the device a positive recommendation. The manufacturer filed a premarket approval with the FDA in May 2011 but as yet, it has not been approved by the FDA.

Source: Anna Azvolinsky, cancernetwork.com, 14 September 2012

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Renal Dernavation May be Cost-Effective for Treating High Blood Pressure

Mon, 17 Sep 2012 11:04:33 GMT

An article in Mass Device reports on a study published in the Journal of the American College of Cardiology which claims that renal denervation is a cost-effective treatment for high blood pressure.

Apparently, the data leading to the latest conclusions has resulted from Medtronic's Symplicity HTN 2 renal denervation trial. The study showed that the catheter-based technique where doctors blast the nerves lining the renal artery with radiofequency energy could be substantially cheaper and more effective than the current standard of care.

Source: Mass Device, 13 September 2012

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Hinge knee implant improves on patients' range of motion

Sat, 15 Sep 2012 12:55:04 GMT

Medical Device Summit reports that Smith & Nephew has launched the Legion HK hinge knee implant in the US and Canada. The manufacturer says that the device uses a rotating technology which has been modelled on natural knee anatomy to improve on patients' range of motion while reducing the stress placed on the hinge link. This, they claim, reduces long-term wear-and-tear.

The article goes on to say that the hinge knee device follows S&N's Legion total knee which has been implanted in about 1 million patients over the last 15 years. The company has said that the new device is designed for patients with highly unstable knees and ligaments that can't support the more common total knee.

Source: Sangita Viswanathan, Medical Device Summit, 12th September 2012

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Expanded FDA clearance for surgical sealer

Fri, 14 Sep 2012 11:55:21 GMT

MedGadget.com reports that Covidien has gained FDA approval to market its LigaSure small jaw instrument, an open sealer/divider, for use in head and neck procedures.

Apparently, the device delivers energy to the tip 3,333 times per second which enables it to seal vessel walls without causing heat damage to surrounding tissue. The article says that the jaw mechanism can be used independent of sealing which enables cutting and blunt dissection. Energy delivery is activated with a hand or foot switch.

The LigaSure small jaw instrument was cleared last year in the U.S. for general surgery.

Source: Gene Ostrovsky, Medgadjet.com, 11 September 2012

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CE Mark for abdominal aortic aneurysm sealing device

Wed, 12 Sep 2012 10:41:39 GMT

Mass Device reports on a press release from Endologix which states that the company has won CE Mark approval for a medical device designed to seal abdominal aortic aneurysms. This is the latest version of the manufacturer's Nellix system.

Apparently, the CE approval does not mean that the device will be available just yet. The press release says that Endologix is implementing enhancements to the Nellix system which are intended to further optimise the device to appeal to the marketplace. When complete, the company will submit the enhancements to its notified body with the expectation of gaining CE Mark approval for the commercial version of the device. This will be followed by a limited market introduction of the system in Europe by the end of the second quarter of 2013.

Source: Mass Device, 10 September 2012

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FDA approves updated heart pump

Tue, 11 Sep 2012 10:25:05 GMT

Cardiovasclar Business reports that the FDA has granted Abiomed clearance on a percutaneous, catheter-based Impella device providing peak flows of approximately four liters of blood per minute.

They say that the increased flow is delivered on the same console platform '9 French' catheter and introduced as the Impella 2.5. The heart pump will be marketed as the Impella CP (Cardiac Power) within the U.S. and is known commercially outside the U.S. as the Impella cVAD.

The FDA clearance designates that the Impella CP has the same indications for use as the Impella 2.5 (i.e., "intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to six hours. It is also intended to be used to provide partial circulatory support (for periods up to six hours) during procedures not requiring cardiopulmonary bypass"). But, this approval includes a limitation in the Impella CP instructions for use.

Apparently, the device is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to six hours. It is also intended to be used to provide partial circulatory support (for periods up to six hours) during procedures not requiring cardiopulmonary bypass.

Abiomed plans a controlled launch with leading heart hospitals in the U.S., with full U.S. commercial availability of the Impella CP expected towards the end of 2013.

Source: Cardiovascular Business, 10 September 2012

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Public to have access to research on medical implants

Tue, 11 Sep 2012 10:04:50 GMT

The Telegraph (UK) reports that for the first time, the public will be able to access details of the clinical research behind medical devices and their safety record since coming on to the market. The rules are being drawn up by the European Commission in the wake of the Poly Implants Protheses breast implant and metal-on-metal hips issues.

Under the current system, the clinical evidence to support devices and the records of adverse incidents linked with them are not openly available. Apparently, manufacturers must share some information with a "nominated body" of their choice which authorises their products for use but it cannot be seen by the public or by independent scientists because of European Union regulations.

British regulators run a voluntary system so surgeons can report concerns about medical devices but the EU confidentiality rules mean their data is not published and patients and doctors are not advised about these concerns.

In January, The Sunday Telegraph disclosed that thousands of Britons had been given metal-on-metal hip implants which were found to poison the body, with some devices having failure rates of up to 50 per cent. Weeks later, the MHRA issued a warning that 49,000 people with the implants should undergo checks throughout their lifetime and undergo further operations to replace the devices if problems were found.

The article says that the new proposals from the EC are due to be published within weeks and are expected to recommend that three directives on medical devices, passed during the 1990s, are rewritten.

Due to the single European market, devices used in this country can be manufactured elsewhere, then authorised by a "notified body" in any of the 27 EU member states. That meant that in the case of the PIP implants, a company in Germany was responsible for the quality of devices produced in France and imported for use in women around the world, including Britain.

The MHRA is also calling for more rigorous standards to ensure that the clinical evidence to support the application for a licence is more consistently and robustly scrutinised.

Read the full article here

Source: Telegraph (UK), 11 September 2012

CE Mark for novolimus eluting coronary stent system

Fri, 07 Sep 2012 14:05:33 GMT

A report states that Elixir Medical has gained CE Mark approval for the DESyne BD novolimus eluting coronary stent system for the treatment of coronary artery disease.

According to the manufacturer, the device has an ultrathin (< 3 microns) biodegradable, polylactide-based polymer coating that does not need an underlying primer layer. Apparently, Elixir's therapeutic compound, Novolimus, is delivered via the polylactide-based polymer to the coronary vessel wall and degrades within 6 to 9 months, leaving behind the cobalt chromium alloy metal stent surface.

The article says that during a trial, the Elixir DESyne BD novolimus eluting coronary stent system was compared with the control Endeavor Zotarolimus eluting coronary stent system. The former demonstrated superiority over the Endeavor stent for the primary endpoint of in-stent late lumen loss at six months. There was also a statistical difference in favour of DESyne BD for the secondary end point of binary restenosis.

The manufacturer reports that the device will be made available in a broad range of sizes.

Source: medicaldevice-network.com, 30 August 2012

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Orthopedic Implant uses Stem Cells to Increase Strength and Longevity

Thu, 06 Sep 2012 13:35:26 GMT

Medgadget reports that University of Glasgow, Scotland, researchers have developed an orthopedic implant that could very well last for the rest of a patient’s life. They say that the key ingredient of the super strong implant is Invibio Biomaterial Solutions‘ PEEK-OPTIMA which is an advanced polymer that is already commonly used in spinal and other orthopedic implants.

Apparently, PEEK is both biocompatible and flexible as its mechanical properties are similar to those of bone. PEEK implants can flex and exercise the surrounding bone which promotes bone regeneration.

The article says that current implants use polyethylene, stainless steel, titanium or ceramic which each have their own drawbacks ranging from biocompatability issues, which could lead to infection, to inflexibility, which can lead to the loss of bone density. Moreover, when an implant is placed, it is usually held in place by a rod that is fixed into the marrow of a bone. Bone marrow, which is rich in stem cells that can differentiate into many different kinds of cells, tends to differentiate into soft tissue, weakening he bond between bone and implant and leading to replacement surgery after 20 or so years.

According to the researchers, the orthopedic implant addresses many of these issues. They say that the implant is covered with a special surface consisting of tiny pits 120 nanometers in diameter. The pitted surface encourages stem cells to differentiate into bone cells and fuse to the implant, creating a much stronger bond between bone and implant.

Source: Scott Jung, Medgadget, 04 Sept 2012

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Infusion device for embolisation procedures gains CE Mark approval

Wed, 05 Sep 2012 11:50:46 GMT

A PR Newswire article hosted by redorbit.com reports that Surefire Medical’s Surefire Infusion System device for chemo and radioembolisation procedures will be immediately launched into Europe now that the product has CE Mark approval.

According to the manufacturer's press release, the device provides interventional radiologists with improved embolisation certainty during their infusion procedures and the system could offer advantages over a standard microcatheter, throughout Europe.

Apparently, in a recent retrospective study of 29 patients, infusion of therapeutic agent with the Surefire Infusion System showed no angiographic evidence of reflux and no clinical evidence of non-target embolisation. Plus, CT imaging in chemoembolisation patients suggested a pattern of increased microsphere tumor penetration and contrast retention.

The Surefire Infusion System received FDA clearance in June, last year.

Source: PR Newswire/redorbit.com

Read the full article here

Neuro clot removal device bests older model for large vessel occlusions

Mon, 03 Sep 2012 11:27:40 GMT

Cardiovascular Business hosts an interesting article on trial results which indicate that patients who have had large vessel occlusion strokes but are ineligible for (or refractory to) intravenous recombinant tissue plasminogen activator should be treated with the Trevo Retriever instead of the Merci Retriever. This is according to the TREVO 2 investigators who have presented the results at the European Society of Cardiology Congress in Munich. The study was also published online in the Lancet.

While rt-PA is the standard of care for treatment of acute ischemic stroke, it has “limitations,” according to the study authors, including a short therapeutic window that restricts more widespread adoption and poor reperfusion rates in the setting of extensive clot burden. As the only alternative to medical therapy, current mechanical devices are unable to achieve recanalization in up to 20 to 40% of large vessel occlusion strokes.

In this open-label, randomised controlled trial, Raul G. Nogueira, MD, professor of neurology and neurointerventionalist at Emory University School of Medicine in Atlanta, and colleagues compared the efficacy and safety of the Trevo Retriever (Stryker Neurovascular), a stent-like device, with its FDA-cleared predecessor, the Merci Retriever (Stryker Neurovascular) by recruiting patients at 26 sites in the U.S. and one in Spain.

The TREVO 2 (Thrombectomy Revascularization of Large Vessel Occlusions in Acute Ischemic Stroke) trial included adults age 18 to 85 years with angiographically confirmed large vessel occlusion strokes and National Institutes of Health Stroke Scale scores of 8 to 29 within eight hours of symptom onset. The researchers randomly assigned patients (1:1) with sequentially numbered sealed envelopes to thrombectomy with Trevo or Merci devices. They stratified randomization by age (at least 68 years vs. 69 to 85 years) and NIHSS scores (at least 18 vs. 19 to 29) with alternating blocks of various sizes.

The primary efficacy endpoint, assessed by an unmasked core laboratory, was thrombolysis in cerebral infarction (TICI) scores of 2 or greater reperfusion with the assigned device alone. The primary safety endpoint was a composite of procedure-related adverse events. The researchers conducted the analysis through intention to treat.

Between Feb. 3, 2011, and Dec. 1, 2011, Nogueira et al randomly assigned 88 patients to the Trevo Retriever group and 90 patients to Merci Retriever group. In the study, 86% of patients in the Trevo group and 60% in the Merci group met the primary endpoint after the assigned device was used. Also, incidence of the primary safety endpoint did not differ between groups (15 percent of patients in the Trevo group vs. 23% in the Merci group).

While the safety profiles were similar with both devices, vessel perforations were almost 10 times more common with the Merci retriever (10 percent) than they were with the Trevo retriever (1 percent). The researchers attributed this perforation rate to a less effective recanalization of the artery, and Trevo is usually deployed by unsheathing the microcatheter compared with the active pushing required with Merci.

Promising results from the SWIFT trial presented at ESC.12 showed the Solitaire Flow device’s (Covidien) superiority over the Merci Retreiver. Nogueira served as a member of the steering committee for SWIFT. The study authors concluded that their trial showed that the Trevo Retriever “was superior to the Merci Retriever for arterial revascularization in terms of reperfusion to TICI 2 or greater in the setting of acute ischemic stroke.

Source: Cardiovascular Business, written by Justine Cadet, 28th August 2012

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FDA approve battery-powered endoscopic surgical stapler

Thu, 30 Aug 2012 10:53:22 GMT

Mass Device has reported on Covidien receiving clearance for its iDrive Ultra Powered surgical stapling system, which the company has called the only fully powered, battery operated and reusable endoscopic stapler available worldwide. According to the company's press release, the device is the 2nd in Covidien's line of powered stapling products and the 1st to fit all of the device maker's Endo GIA staple reloads.

The device features one-handed operation and improve maneuverability and is designed for multi-patient use. Covidien plans to begin selling the device in the US towards the end of the year.

The article goes on to describe how last week Covidien discontinued certain Duet TRS single-use surgical stapling systems following reports of patients deaths and injuries. According to a press release, the company cut the Duet TRS Universal Straight and Articulating Single-Use Loading Units following a single report linking the tissue reinforcement devices to a post-operative injury.

Source: Mass Device, 28th August 2012

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New treatment for high blood pressure patients a 'potential revolution'

Thu, 30 Aug 2012 10:24:00 GMT

Reuters has reported on how Europeans suffering from high blood pressure, despite taking oral medication, now have a new renal dernavation treatment option in the form of devices that deaden nerves in the kidneys.

The United States has yet to approve the technology but several products are already available in Europe and researchers reported encouraging results from a series of studies testing them out in practice.

Teams from Germany, France and the Czech Republic told the European Society of Cardiology annual meeting that the new procedure offered benefits to a range of patients and seemed to effectively rejuvenate ageing blood vessels.

Reuters say that the millions of people with hypertension resistant to drug therapy - putting them at risk of heart attacks and stroke - has encouraged several medical technology companies to invest in device-based high blood pressure treatments. Device makers that have already received approval to sell hypertension devices in Europe include Medtronic, the frontrunner, as well as Covidien, St Jude Medical, ReCor Medical and Vessix Vascular.

The new devices work by creating tiny scars along nerves in the kidneys - organs which play a pivotal role in regulating blood pressure by sending signals to the brain that can cause blood vessels to constrict. The scarring process is carried out by threading a catheter through the renal arteries from the groin. It deadens the nerves and decreases blood pressure. So far, there do not seem to be any worrying long-term side effects.

Cardiologists meeting in Munich said the technique had the potential to change blood pressure management and could in future be offered to a wider range of patients, not just those with the most obstinate hypertension.

Dr Gordon Tomaselli, a cardiologist at Johns Hopkins and president of the American Heart Association was quoted as describing the treatmant as a 'potential revolution'.

Apparently, Dr Michael Boehm of Germany's University Hospital, Saarland, said that around 12,000 patients had now been treated in Europe, most of them in Germany, although the procedure was expensive, with each catheter costing approximately 3,750 euros ($4,700).

Source: Reuters, (Editing by Helen Massy-Beresford), 27 August 2012

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Mixed reactions to latest coronary stenting study

Thu, 30 Aug 2012 09:46:22 GMT

More findings and analysis from St. Jude Medical's Fame II trial, studying fractional flow reserve-directing coronary stenting, have been made available.

According to the manufacture, patients who received percutaneous coronary intervention in addition to drug therapy were better off than patients who took drugs alone. However, a Mass Device article reports that some questions on the results have been raised in the market place.

The article goes on to say that patients in one area of the study received percutaneous coronary intervention guided by fractional flow reserve technology to measure and identify blood vessel narrowings and determine which are obstructing blood flow to the heart. Those patients also received "optimal medical therapy," an anti-platelet and beta blocker drug regimen.

Source: Mass Device, 28th August 2012

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Award winning hybrid vascular graft earns CE Mark

Wed, 29 Aug 2012 10:20:21 GMT

WL Gore and Associates has announced that its award-winning Gore Hybrid Vascular Graft has been granted the CE Mark approval. The device has been available in the US since 2010 and has been proven to expand treatment options for optimal outflow by maximising the number of access sites available.

Designed as a vascular prosthesis for replacement or bypass of diseased vessels impacted by aortic aneurysmal, peripheral vascular and end-stage renal disease, it is able to address common causes of graft failure, such as intimal hyperplasia, thrombosis and seroma.

More than 2,500 successful implants for dialysis access and other vascular procedures have taken place since the product's US debut.

The company took gold for the device at the 2012 Medical Design Excellence Awards, in July.

Source: Medical Company Product News, 22 August 2012

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Reports indicate performance issues with Zimmer knee implants

Tue, 28 Aug 2012 09:56:58 GMT

In 2003 Zimmer introduced the NexGen CR-Flex knee implants and marketed the device as an improvement over older devices. Instead of providing a femoral component that was cemented to the bone, as was the case in traditional knee replacements, the CR-Flex replaced the cement with a porous liner that would keep the implant in place by encouraging bone growth between its components.

Renowned orthopaedic surgeon and former Zimer Consultant, Dr. Richard Berger, who taught correct surgical technique for high flex NexGen knee replacement procedures, personally implanted several of the CR-Flex devices. When following up on patient progress, however, he discovered that in many cases the femoral component had failed to fuse with the thighbone.

In March 2010, Dr. Berger and his colleague, Dr. Craig Valle, from Rush University Medical Center, reported on a study of 108 patients. The study showed that 36% of the participants suffered from premature loosening of the implant and 8.3% required revision surgery. They recommended that the device should be removed from the market but Zimmer disagreed and responded that the problems were a result of surgical error. Dr. Berger’s contract with Zimmer was not renewed following the publication of the study.

Critics assert that Zimmer failed to discover the potential problems with the Zimmer NexGen line of implants prior to market launch because they failed to conduct clinical trials on the device. Instead, they sought FDA approval through the fast-track 510(k) approval process which requires only that the implant be substantially similar to a product already on the market. As a result, many patients were implanted with NexGen devices that may not have been adequately tested.

A later study, presented on February 9, 2012 to the American Academy of Orthopedic Surgeons, confirmed that the Zimmer NexGen tibial component was linked to higher than expected failure rates. Researchers at the Mayo Clinic reviewed data from over 1,000 patients who went through knee replacements between 2000 and 2011. Complications from the NexGen system were 3.9% and half of those involved premature loosening. Most of the loosening cases were because the tibial component separated from the bone.

Source: Eric Chaffin, New York Times, 22 August 2012 (U.S.)

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Research grant received for breast cancer diagnostic device

Tue, 28 Aug 2012 09:31:18 GMT

In the U.S., a breast cancer diagnostic startup that uses fingertip sensors to detect tumors has received a research grant of more than $878,000 to advance its handheld diagnostic device.

UE Lifesciences’ Intelligent Breast Exam can distinguish between normal breast tissue and a tumor. The device has been particularly effective at detecting tumors in women under 40, based on the clinical trials the college of medicine has conducted. The Commonwealth Universal Research Enhancement grant will be used to advance the screening test to the final stages of development.

In a pilot clinical study conducted at Drexel’s College of Medicine, the device detected 9 out of 11 clinician non-palpable breast tumors and identified one invasive breast cancer that was missed on the mammogram. The Philadelphia-based diagnostics start-up licensed the technology from Drexel University in 2010. Dr. Wan Shih, who has had breast cancer herself, developed the early versions of the device as part of a research project she led at Drexel University’s School of Biomedical Engineering, Science and Health Systems.

It specialises in developing automated technologies that don’t require highly skilled medical practitioners to carry out accurate tests and data analysis. Earlier this year another breast cancer detector from UE Lifescience won approval from the FDA. The radiation free, “No Touch Breast Scan” uses computerised, functional infrared imaging system that analyses temperature pixels from infrared frames to identify physiologic signs of developing breast cancer.

In an interview with Flying Kite Media earlier this year, UE Lifesciences CEO Mihir Shah said infared technology has been able to pinpoint tumors in cases where mammography has failed, particularly for women with dense breasts. There are 13,000 mammography centers in the U.S. but only 400 U.S. clinics offer breast thermography. Improvements and affordability of digital cameras are making thermography a more realistic alternative to traditional mammograms.

Source: Stephanie Baum, medcitynews.com, 20 August 2012 (U.S.)

Read the full artticle here

Wound-healing device to have UK clinical trial

Tue, 28 Aug 2012 10:27:35 GMT

An ultrasound device to heal wounds and ulcers through mist emmissions will undergo a clinical trial in the UK.

The National Institute for Health and Clinical Excellence (NICE) said last year that more research was needed to show the efficiency of Celleration’s MIST Therapy System before it can be approved for use in Britain's National Health Service. The technology will be tested on 40 patients to determine whether it heals wounds better than existing treatment.

The trial will be carried out by Cardiff University and the Cardiff and Vale University Health Board. NICE’s Medical Technologies Advisory Committee sought the research last year after deciding there wasn’t enough evidence to recommend that the NHS pay for the treatment.

“There is a small amount of evidence to suggest that ulcers treated with MIST will heal more quickly than those having usual treatment,” said Keith Harding, investigator at the Wound Healing Research Unit at Cardiff University. “This trial will enable us to generate more independent evidence to show if this is actually the case.”

The device uses low-intensity ultrasound waves delivered through saline mist which encourages repair by stimulating cells below a wound. The therapy reduces inflammation and provides painless treatment that makes no contact with the lesion.

Source: Mehreen Khan, bloomberg.net, 24 August 2012

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CE approved defibrillators offer a new approach to CRT treatment

Sat, 25 Aug 2012 10:40:35 GMT

Medtronic has won CE Mark approval for its Viva/Brava line of cardiac rhythm management devices. The medical device company said the Viva and Brava products, which are cardiac resynchronization therapy with defibrillation devices, feature a new algorithm it calls AdaptivCRT designed to optimize their CRT-D treatment.

The Viva/Brava family of devices offers clinicians and their patients a new approach to CRT treatment, providing therapeutic benefit and individualized care for patients

The AdaptivCRT software helped reduce right ventricular pacing by 44%, reducing unnecessary treatment and prolonging the life of the devices. The software also met its pre-specified safety and efficacy endpoints of non-inferiority as compared to the gold-standard comprehensive echocardiography-guided biventricular pacing, data. This is the basis for its pre-market approval application with the FDA.

Source: Mass Device, 20 August 2012

New coronary stent wins CE Mark

Sat, 25 Aug 2012 13:25:43 GMT

Abbott's Xience Xpedition coronary stent has won CE Mark approval and the company plans an immediate launch in European countreis that recognise the Mark.

The company described the device as approved to treat patients with diabetes and requiring 3 months of dual-antiplatelet drug therapy, which the company hails as the shortest duration required for any major drug eluting stent offered in Europe.

According to Abbott's press release, "Long-term compliance to DAPT can be a challenge for patients and can lead to additional safety risks such as increased bleeding events. Having a shorter DAPT duration after stent implantation may be beneficial in case a patient needs to interrupt or discontinue the medication prior to surgery or for other considerations."

Earlier this year, Abbott won regulatory approval in Japan for its Xience Prime cobalt-chromium drug-eluting stent. Now that Johnson & Johnson's Cordis subsidiary has ceded the coronary stent market to its rivals, Abbott, Boston Scientific and Medtronic are each attempting to dominate the sector. In April, data showed that Medtronic's Resolute stent proved non-inferior to Abbott's Xience in an off-label study, which included "live" uses, in patients with complex lesions.

Source: Mass Device, 20 August 2012

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Call for FDA to overhaul medical device databases

Thu, 23 Aug 2012 10:36:08 GMT

2 members of Congress are calling on the DA to overhaul databases providing public information about the safety of medical devices that rarely undergo clinical trials. Legislation introduced in February would allow the FDA to reject an application for a new device if it is modeled on an earlier product that has been taken off the market after causing harm. The bill remains pending in the House of Representatives.

In the absence of legislation being enacted, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) have sent a letter to the FDA with several questions to assess the agency’s willingness to make certain changes, including:

* Updating the 510(k) database to indicate devices that have been recalled for design flaws that could affect safety or effectiveness

* Update the database within 30 days after completing a review of a manufacturer’s root-cause analysis that concludes a flaw triggering a recall was serious

* Include in the database clearly marked past recalls for serious design flaws that could affect safety or effectiveness

* Revise the 510(k) Premarket Notification database to notify the public that a certain product repeats the same design flaw that caused a predicate’s recall

Source: healthdatamanagement.com, 20 Aug 2012

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Surgical staples discontinued after patient injuries and deaths

Thu, 23 Aug 2012 10:42:25 GMT

Covidien has discontinued certain Duet TRS single-use surgical stapling systems after reports of patients deaths and injuries. The medical device company removed the Duet TRS Universal Straight and Articulating Single-Use Loading Units from the market following a report linking the tissue reinforcement devices to a post-operative injury. This is in addition to 13 serious injuries and 3 patient deaths that spurred a recall and FDA warnings of possible mismanagement of the recall.

In January, Covidien recalled all of its Duet TRS single-use heads for thoracic surgery, modifying the product's instructions and warning against use in thoracic procedures. Covidien reported that the device has the potential to injure adjacent anatomical structures within the thorax which may result in life-threatening post-operative complications. The manufacturer also placed a hold on the global Duet TRS inventory in order to conduct the relabeling.

Then, in June, the FDA asked Covidien to defend its management of the recall and remarked on a lack of sufficient documentation and delayed response to reports which were first noted more than 2 year before the recall took place.

The recall and the new notice affect 8 models of straight and articulating Duet cartridges which are endoscopic stapling systems with preloaded tissue reinforcement material. The cartridges attach to GIA universal stapler handles. Covidien has sold more than 540,000 units worldwide.

This week, Covidien has also recalled grounding pads contained in ablation device kits after at least 4 patients experienced serious injuries and burns at the pad site.

Source: Mass device, 22 August 2012

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Covidien recalls electrode kits

Wed, 22 Aug 2012 09:15:28 GMT

Covidien has announced the 2nd recall in as many months of its tumor ablation kits. This follows the occurence of at least 4 patients being burned by grounding pads. The manufacturer has recalled the pads and the Cool-tip RFA ablation systems that contain them.

The Cool-tip RFA system is an ablation device that may be used as an alternative to surgery for some cancers in the liver or other soft tissue. The device in won FDA clearance in May 2006 for use in non-resectable liver tumors.

The kit delivers radiofrequency energy which heats and destroys target tissue, either through open surgery, percutaneously or laparoscopically based on a physician's preference. The 4 single-use grounding pads go across the thighs and it is this component that has caused the issue. Covidien recalled certain lots of the pads and the kits manufactured prior to August 30, 2011, according to the recall notice.

In June the FDA asked Covidien to defend its management of the recall of its Duet TRS surgical staples which were removed from the shelves after they were implicated in 13 patients injuries and 3 deaths.

Source: Mass Device, 20 August 2012

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Alert on St. Jude Heart Device

Wed, 22 Aug 2012 13:00:14 GMT

Cardiologist, Dr. Robert G. Hauser of Abbott Northwestern Hospital in Minneapolis, has called for surgeons to stop using the Durata defibrillator lead until more is known about its long term safety. He made his comments as study he conducted, anticipated by analysts and industry-watchers, was published in the online journal Europace.

Dr. Hauser's research suggests that a coating used on wires that connect an implanted defibrillator to a patient’s heart is breaking down prematurely and, in some cases, leading to failure of the device. The study was published by EP Europace, a British cardiology journal.

Dr. Hauser had previously connected at least 20 deaths to an earlier generation of defibrillator leads, the wiring that runs from the device into the heart. St. Jude has pulled those products from the market but Hauser now says his work indicates that newer products are not immune to the underlying problem in which the coating of the wires wears away.

St. Jude began using the coating, known as Optim, several years ago as a means of better protecting its leads from abrasion. However, Dr. Hauser said a troubling number of cases had been reported to the FDA in which the Optim coating appeared to fail. The company has defended the safety of Optim and its Durata device which has been implanted in an estimated 278,000 patients worldwide. St. Jude has said defibrillators with its coating, which insulates wires on the company's Durata and Riata ST Optim defibrillator leads, are among the most wear-resistant and safest on the market. The company says the Optim coating is 50 times more abrasion-resistant than standard silicone-only leads.

While Hauser found that the Optim-coated leads are not immune to abrasion, he did not find instances of wires working their way outside the insulation of the Durata leads. Such "inside-out" abrasion has plagued St. Jude's now-recalled Riata defibrillator leads. In some cases the abrasions to the Optim-coated leads resulted in high-voltage failures and one death. What isunknown and requires more study, according to Hauser, is how often Optim leads fail because of damaged insulation.

Last week, the FDA announced that it is requiring studies of the Riata and other recalled St. Jude leads. It recommended patients with Riata leads get flouroscopic X-rays to check for abnormalities, and, it required that St. Jude studys its Durata leads. In May, the company noted that its study of Optim-coated leads showed no instances of externalised conductors caused by inside-out abrasion. In addition, the leads had a "99.96 percent rate of freedom from all-cause insulation abrasion" and "99.84 percent rate of freedom from all-cause mechanical failure."

Hauser gathered data from the FDA's Manufacturers and User Device Experience (MAUDE) database on April 13, searching for reports of lead abrasion. He said he found 15 reports for Riata ST Optim and 37 reports for Durata leads. The reports had been submitted by St. Jude Medical between December 2007 and January 2012 based on its analysis of returned leads.

Eight of 15 Riata ST Optim leads had "can" abrasions from rubbing against the defibrillator itself and three abrasions were most likely caused by friction with another lead. Four of these abrasions resulted in high-voltage failures and one death, Hauser said. In the Durata reports, 12 had "can" abrasions and six had abrasions caused by friction with another device. Of these 18 abrasions, Hauser said, 13 had electrical abnormalities.

Source: Batty Meier & Katie Thomas, New York Times, 21 August 2012. Read the NYT article here

Source: James Walsh, Star Tribune, 21 August 2012. Read the Star Tribune article here

UPDATE: St. Jude Medical has issued a detailed statement as follows:

There are a number of ways a lead may fail, including dislodgement, fracture (breaking of the lead), and abrasion (e.g. wear on the lead due to friction against another object). These failures can result in impedance changes, noise, under- and oversensing, an inappropriate shock, an electrical short or, in the most serious cases, a failure to provide therapy. As part of our commitment to communicating with the clinical community about device performance, lead failures are reported in our biannual product performance report, including in the Focus on Clinical Performance section. Failures are associated to some degree with leads from all manufacturers and may also be the result of the harsh environment that these leads must endure.

While no lead is perfect, bench testing has demonstrated that the Optim material is 50 times more abrasion resistant than silicone insulation. Although not mentioned in the manuscript, St. Jude Medical also has the largest prospective, actively monitored lead registries in the industry, including our OPTIMUM registry of Optim insulated leads. Additionally, we announced in March that we have appointed Population Health Research Institute (PHRI), an academic health science research institute, to analyze data from three combined prospective, actively monitored registries involving approximately 11,000 patients enrolled at 292 sites, with more than 5 years and 27,000 patient-years of data, which are documenting the performance of our current-generation leads. In fact, we recently announced that we are expanding our OPTIMUM study follow-up duration to follow patients enrolled in the registry indefinitely.

St. Jude Medical is committed to continuing to make significant investments in technologies and post-market surveillance studies to further advance our insight into the performance of our leads, and to improve patient safety.

Update extracted from medcitynews.com article by Arundhati Parmar, 21 August 2012

Full article here

New MHRA guideline: annual checks on metal hip recipients

Tue, 21 Aug 2012 11:33:44 GMT

Patients with a common type of metal hip implant should have annual health checks for as long as they have the implant, according to the MHRA. The all-metal devices have been found to wear down at an accelerated rate in some patients, potentially causing damage and deterioration in the bone and tissue around the hip. There are also concerns that they could leak traces of metal into the bloodstream, which the annual medical checks will monitor.

Hours before critical coverage from the BMJ and the BBC, the MHRA issued new guidelines on larger forms of ‘metal-on-metal’ hip implants. Advice on smaller metal devices or those featuring a ceramic head has not changed. Previously, guidelines suggested larger implants should only be checked annually for 5 years after surgery. The agency now says the annual check-ups should be continued for the life of the implant as a precautionary measure to reduce the “small risk” of complications and the need for further surgery.

There are numerous designs and materials used to make hip implants. In recent days the MHRA has issued major updates to its advice on a type of metal-on-metal (MoM) hip replacement. As the name implies, MoM implants feature a joint made of two metal surfaces – a metal ‘ball’ that replaces the ball found at the top of the thigh bone (femur) and a metal ‘cup’ that acts like the socket found in the pelvis.

The MHRA’s updated advice concerns the type of MoM implant in which the head of the femur is 36mm or greater. The agency now says that patients fitted with this type of implant should be monitored annually for the life of the implant and that they should also have tests to measure levels of metal particles (ions) in their blood. Patients with these implants who have symptoms should also have MRI or ultrasound scans and patients without symptoms should have a scan if their blood levels of metal ions are rising.

It is estimated that 49,000 people in the UK have been given metal-on-metal implants with at minumum width of 36mm. This represents a minority of the patients given hip replacements, who mostly have devices featuring plastic, ceramics or smaller metal heads. In 2010 there were 68,907 new hip replacements fitted, and approximately 1,300 of these surgeries used an MoM implant sized 36mm or above – a rate of around 2%.

All hip implants will wear down over time as the ball and cup slide against each other during walking and running. Although many people live the rest of their lives without needing their implant to be replaced, any implant may eventually need surgery to remove or replace its components. Surgery to remove or replace part of the implant is known as ‘revision’ and, of the 76,759 procedures performed in 2010, some 7,852 were revision surgeries.

However, data now suggest that large head MoM hip implants (those with a width of 36mm or greater) wear down at a faster rate than other types of implants. As friction acts upon their surfaces it can cause tiny metal particles (medically referred to as ‘debris’) to break off and enter the space around the implant. Individuals are thought to react differently to the presence of these metal particles, but, in some people, they can trigger inflammation and discomfort in the area around the implant. Over time this can cause damage and deterioration in the bone and tissue surrounding the implant and joint. This, in turn, may cause the implant to become loose and cause painful symptoms, meaning that further surgery is required.

News coverage has also focused on the MHRA’s recommendation to check for the presence of metal ions in the bloodstream, potentially released either from debris or the implant itself. Ions are electrically charged molecules. Levels of ions in the bloodstream, particularly of the cobalt and chromium used in the surface of the implants, may, therefore, indicate how much wear there is to the artificial hip.

There has been no definitive link between ions from MoM implants and illness, although there has been a small number of cases in which high levels of metal ions in the bloodstream have been associated with symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system and thyroid gland.

The MHRA advises that most patients with MoM implants have well functioning hips and are thought to be at low risk of developing serious problems. However, a small number of patients with these hip implants develop soft tissue reactions to the debris associated with some MoM implants.

Source: Dinnington Guardian, 20 August 2012 (UK)

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Technological breakthrough could reduce medical device failure

Tue, 21 Aug 2012 14:53:41 GMT

A new material that is resistant to bacteria and stops biofilm formation has been discovered by scientists at the University of Nottingham, according to a recent study in Nature Biotechnology. The material consists of ester and cyclic hydrocarbon moieties that resist bacteria such as Pseudomonas aeruginosa, Staphylococcus aureus and Escherichia coli.

When researchers coated silicone with the new material, it reduced the amount of pathogenic bacteria on surface areas by 96.7% compared to the now-available silver hydrogel-coating, in vitro, according to the abstract of the study. Both coatings were equally effective, however, when compared in an in vivo mouse infection model.

The report indicates that the discovery could help reduce infection and medical device failures. The new group of structurally related materials dramatically reduce the attachment of pathogenic bacteria. The technology, developed with the help of the Massachusetts Institute of Technology, means that hundreds of materials could be screened simultaneously to reveal new structure-property relationships.

Source: Healio.com: Orthopedicstoday, 14 August 2012 (U.K.)

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Reference: Hook AL, Chang Y, Yang J, et al. Kinematic combinatorial discovery of polymers resistant to bacterial attachment. Nature Biotechnol. 2012. Published online before print August 12, 2012. doi:10.1038/nbt.2316.

Doctors question FDA guidance on flawed heart device

Mon, 20 Aug 2012 13:58:03 GMT

In the U.S., the FDA's advice to routinely X-ray patients with a flawed St. Jude's Riata defibrillator lead has prompted top heart doctors to question the reasoning behind this decision. The agency doesn’t recommend that doctors treat patients any differently if they detect flaws and this coulod mean potentially subjecting thousands of patients to unnecessary medical tests.

The lead connects the heart to devices that shock irregular rhythms back to normal. Wires inside Riata leads, which St. Jude stopped selling in 2010 and were recalled last year, are prone to breaking through their insulation. In an unknown share of cases with insulation problems, the leads also have life-threatening electrical malfunctions.

X-rays can detect extruded leads to reveal loose wires floating in the heart. However, removing them can be dangerous and as St. Jude has pointed out, many extruded or externalized leads continue working normally. The FDA has therefore suggested that doctors watch patients carefully, mirroring the same guidance they offer for normal Riata devices.

The FDA is requiring St. Jude to conduct new studies to gather more information about the failures and management of patients with Riata leads.

A 2010 study of a commonly used techniques to remove the leads found that major complications occurred in about 1.5% of patients although doctors at some elite facilities who specialise in removing leads have lower complication rates. Cardiologists typically agree the procedure should only be performed by practiced experts.

Source: Christopher Weaver, Wall Street Journal, 17 August 2012 (U.S.)

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U.S. tax on knee or hip replacement devices provokes a debate

Mon, 20 Aug 2012 14:26:23 GMT

The many baby boomers considering hip or knee replacements in the coming years are likely to have to pay more for them. The debate is, how much more will this be and could could the problems stretch beyond a higher price tag?

Under the Affordable Care Act, the Obama administration's signature health care reform law, medical-device manufacturers will pay a 2.3 percent tax on sales of such products starting in 2013. That tax will affect everything from surgical tools to oxygen tanks to wheelchairs. It is one of several features of the law designed to raise money to cover the uninsured. It is expected to raise an additional $20 billion by 2019.

However, experts predict that the tax may have a particularly big impact in the world of knee and hip replacements. Such operations increased more than 26 percent to more than 1 million procedures in the U.S. between 2005 and 2010, according to the American Academy of Orthopaedic Surgeons. With the American population hitting retirement age in record numbers, demand is likely to surge. The number of knee replacement procedures alone is expected to increase 673 percent, to nearly 3.5 million, in 2030, according to a study presented at the annual meeting of the orthopedic academy.

Some critics of the tax estimate that the expense could add hundreds of dollars to the cost of each joint-replacement procedure, as the manufacturers of the joints pass the cost along to patients.

Medical-device manufacturers contend that while the tax may seem relatively small, it would amount to $230 on the sale of a $10,000 medical device. Several medical companies say that the surcharge would eat into their profitability at the expense of their research and development budgets. Orthopedic device maker Stryker says that in anticipation of the tax, it plans to cut more than $100 million from its annual pretax operating costs next year. Smaller device maker Zoll Medical says the new surcharge will raise its overall rate above 50 percent and use up its entire R&D budget.

"If companies focus just on products that generate higher sales volumes, they may discontinue specialised models, leaving doctors and consumers with fewer options", says Julie Stralow, an orthopedics analyst at Morningstar.

No industry likes to face a tax increase and some advocates of the health-care act say that manufacturers are overstating its potential impact. Other insiders are optimistic that scenarios like the ones the companies describe might not come to pass. Until the tax takes effect, its impact on consumers will remain unclear. It may well be that for some patients, the physical pain prior to surgery is so high they may regard the additional cost of the solution is worth it.

Source: Jen Wieczner, SmartMoney,com, 17 August 2012 (U.S.)

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Gastro-esophageal reflux disease system wins CE mark

Mon, 20 Aug 2012 14:41:53 GMT

EndoStim has received CE mark approval for its LES Stimulation system, designed to treat gastro-esophageal reflux disease (GERD) and eliminate the need for daily proton pump inhibitor (PPI) medication. By using low energy electrical pulses, the EndoStim system will strengthen a weak or dysfunctional lower esophageal sphincter (LES) muscle, which is the underlying cause of GERD.

EndoStim has received CE mark approval for its LES Stimulation system, designed to treat gastro-esophageal reflux disease and eliminate the need for daily proton pump inhibitor medication. By using low energy electrical pulses, the device will strengthen a weak or dysfunctional lower esophageal sphincter muscle which is the underlying cause of GERD.

The CE mark approval is based on a multicenter trial, conducted in Santiago, Chile, to demonstrate the safety and efficacy of the LES Stimulation system. The results demonstrated improvement in acid reflux while allowing for normal esophageal function such as swallowing and belching as well as both daytime and night time improvement in heartburn symptoms and regurgitation. The 12 months data also indicate that 100% of patients who received EndoStim treatment for 12 months were able to stop daily PPI, while 77% achieved normalisation or greater than 50% reduction in abnormal esophageal acid exposure.

The company said it has begun enrollment patients in a commercial registry study and is planning for a US study to begin in late 2013.

Source: MDBR Staff Writer, MDBR Edoscopy Devices, 20 August 2012 (U.S.)

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New device removes clogs in feeding and decompression tubes

Thu, 16 Aug 2012 09:39:52 GMT

Brand new device, TubeClear, removes clogs in medical feeding and decompression tubes. Reusable control boxes and single-use cleaning stems mechanically clear clogs which means that tubes do not need to be removed or replaced thereby reducing disruption to the delivery of nutrition and medication.

The device, which took 4 years to develop, is the first to be brought to the U.S. market by Actuated Medical. The manufacturer has further devices in the pipeline.

Source: Elise Vider, Keystonedge 16 August 2012

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Minaturised microscope detects bile duct tumors

Thu, 16 Aug 2012 09:41:31 GMT

A new minutare microscope has the potential to detect cancer in harder to access areas of the body. The probe based confocal laser endomicroscope is under 7 millimeters in diameter - small enough to fit inside a bile duct where it takes real-time videos, which, following analysis, could lead to improved rates on detecting bile duct cancer.

However, the 10-15 doctors in the country (U.S.) trained to use the groundbreaking device may not be certain about or agree on what the micropscope's videos show, according to study published recently in Digestive Diseases and Sciences.

To test the interpretation of the videos, a research team was despatched to 6 specialists at 5 medical institutions where footage from the examinations of 25 patients with abnormally narrowed bile ducts was viewed. The doctors were in "poor" to "fair" agreement on what they were actually seeing in the videos and that their diagnoses ranged from cancer to simple inflammation.

Researchers using the device are now meeting regularly to revise and standardise the analysis of the videos. Once clarified, it is likely that the “mini-scope” will help doctors catch cancer earlier and know more clearly which bile duct tumors need to be removed.

Source: Christine Roberts, New York Daily news, 14 August 2012

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FDA approval for new clot removal device

Wed, 15 Aug 2012 13:51:33 GMT

Stryker Neurovascular's Trevo Pro Retriever has been granted market clearance by the FDA. The device, launched in Europe in 2010, uses the manufacturer's Stentriever technology for optimised clot integration and retrieval in patients experiencing acute ischemic stroke.

Earlier this year, results of the Thrombectomy REvascularisation of large Vessel Occlusions in acute ischemic stroke study were presented at the International Stroke Conference. 60 patients were enrolled by 7 leading European stroke centers. The study assessed the ability of the Trevo system to remove the blood clots that cause strokes and to restore blood flow to the brain.

Revascularisation, measured by an independent lab, showed high rates in 91.7% of patients. 46% achieved a good outcome in 7 days and at 90 days, the good outcomes rate increased to 55%. Furthermore, the patients with good outcomes were functionally independent (modified Rankin score of 2 or less). A low symptomatic intracranial hemorrhage rate of 5% was also reported.

The Trevo Pro Retriever also demonstrated strong clinical results in the TREVO 2 clinical trial presented at the European Stroke conference in May, this year.

Source: Amanda Pedersen, Medical Device Daily Senior Staff Writer, Medical Device Daily, 14 August 2012

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FDA pre-market approval for implantable device to treat spasticity

Mon, 13 Aug 2012 10:51:42 GMT

Codman & Shurtleff Inc., part of the Depuy Synthes companies, has received a premarket approval from the FDA to market a neuromodulation product that treats spasticity.

The MedStream Programmable Infusion System is implanted in the abdomen and can deliver antispasm drug baclofen directly into the spinal canal through a catheter to relieve the symptoms of severe spasticity. Spasticity affects 12 million in the U.S. and is a movement disorder often caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury. The device is intended to be an alternative for taking drugs orally.

The pump is about 3 inches in diameter and about 1-inch thick, and is attached to the SureStream Catheter that transports the drug into the spinal canal. Doctors use a computerized control unit to wirelessly deliver correct drug dosage and rate of flow for each patient.

The MedStream Programmable Infusion System is already approved in Europe and will be rolled out in a phased launch for the U.S. market.

Source: medcitynews.com, August 7, 2012

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Heart device sustains babies & children suffering from heart failure

Mon, 13 Aug 2012 11:37:31 GMT

The Berlin Heart, a pediatric ventricular assist device (VAD), was approved by FDA in December 2011, for use in children and babies. It has been implanted in approximately 1,000 children awaiting heart transplants worldwide. Small flexible tubes are placed in the child’s failing heart, extend through the skin and connect to a pump outside the body. The pump and a computerised drive unit help maintain blood flow.

Following approval, a team of researchers from 17 institutions, led by Texas Children's Hospital and Baylor College of Medicine, set out to measure the Berlin Heart’s effectiveness and patient survival rate against other, more traditional therapies for pediatric heart failure. They called the results, published in the New England Journal of Medicine, “unprecedented.”

Principal investigator Dr. Charles Fraser, surgeon-in-chief at Texas Children’s Hospital and professor of surgery and pediatrics at BCM, told FoxNews.com there are not a lot of suitable donors for children – usually only 70 to 80 small donor hearts become available in a given year. “Almost a third of children die on the waiting list,” Fraser said. “But [the Berlin Heart] now allows patients to be on the list longer, and therefore have a better chance of surviving to receive a heart transplant.”

• Compared to the previous standard of therapy, known as extracorporeal membrane oxygenation (ECMO), the median survival time of infants (average age: 1 year old) was 28 days compared to five days on ECMO. The longest survival time was 174 days on the Berlin Heart compared to 21 days on ECMO.

• By 174 days, 88 percent of children on the Berlin Heart had been successfully transplanted, while 12 percent had died or failed weaning. In comparison, at 21 days, 25 percent of children on ECMO had died.

• Meanwhile, the median survival time of older children (average age: 9 years old) was 43 days on the Berlin Heart compared to five days on ECMO. The longest survival time was 192 days on the Berlin Heart, compared to 28 days on ECMO.

• At 192 days, 92 percent of children on the Berlin Heart had been successfully transplanted or weaned off the device, while 33 percent of children on ECMO had died within 30 days.

In addition, children on the Berlin Heart experienced other benefits in quality of life.

In the study, the researchers noted risks associated with the Berlin Heart – including major bleeding, infection, high blood pressure and a higher-than-expected rate of stroke. However, these risks generally did not appear to impede patients from receiving a transplant, they added.

Source: foxnews.com, 09 August 2012

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FDA approves new ultrasonic surgical device

Mon, 13 Aug 2012 11:17:23 GMT

Ethicon Endo-Surgery has received FDA clearance forthe HARMONIC ACE+ shears. The device uses adaptive tissue technology which enables it to respond to varying tissue conditions by regulating energy delivery and providing surgeons with enhanced audible feedback.

The ultrasonic surgical device is designed for a range of specialties and procedures which include general, bariatric, colorectal, GYN and urology.

Source: Becker's ASC Review, 09 August 2012

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FDA approves balloon expandable stent system

Sat, 11 Aug 2012 10:33:54 GMT

Abbott has won FDA approval for the Omnilink Elite balloon expandable stent system which is the latest in the company's range of peripheral vascular intervention devices. The device is used in the treatment of atherosclerotic iliac artery lesions, a condition affecting the lower extremities which can lead to chronic pain, difficulty with walking or permanent disability.

The Omnilink system is based on Abbott's Multi-Link coronary stent's design but it is manufactured from a cobalt-chromium alloy which, according to the company, is stronger than stainless steel and more easily visible in imaging.

FDA approval was supported by data from Abbott's Mobility study which compared the Omnilink Elite stent system alongside the Absolute Pro stent system. Both devices performed well under the major adverse event goal of 19.5% even among patients with difficult-to treat lesions. The Omnilink Elite resulted in a 5.4% MAE rate and the Absolute Pro in a 6.1% rate. MAEs were defined as death due to any causes, myocardial infarction, clinically-driven target lesion revascularisation and limb loss via major amputation on the treated side.

More details here

FDA limits use of Stryker's Wingspan brain stents

Fri, 10 Aug 2012 10:07:47 GMT

The FDA has limited use of Stryker's Wingspan brain stent system to a narrower group of patients after studies suggested the device may increase stroke and death rates.

The system's use is now restricted to those with recurrent stroke who, despite medical management, have not experienced new stroke symptoms within seven days before treatment with Wingspan.

The FDA notice included that, "While Wingspan is not beneficial for the broad population of stroke patients studied in SAMMPRIS there is evidence from the original HDE study to show there are probable benefits of using Wingspan to treat the specific population of patients outlined in the new indications for use."

As a result, Wingspan devices, approved in 2005, won't be recalled.

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New chronic pain relief device for diabetics

Wed, 08 Aug 2012 10:14:50 GMT

NeuroMetrix Inc's Sensus pain management device has been approved by the Food and Drug Administration. The company hopes that the device should reach the US market before the end of the year. The Sensus is a non-invasive electrical nerve stimulator that is designed to provide relief from chronic pain.

People likely to benefit from the device are diabetics with nerve-related complication, diabetic neuropathy. In many cases, these diabetics now use medication to manage pain. The hope is that the Sensus could eliminate or reduce their need for pain-management drugs.

The Sensus is designed to be worn around a patient’s upper calf and pain relief is initiated by pressing a button that causes electrical stimulation of the nerves. The physiological principle is that excitation of normal nerves reduces transmission of pain signals to the brain.

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Positive trial results for abdominoplasty scar therapy

Wed, 08 Aug 2012 10:31:20 GMT

Neodyne Biosciences has announced positive interim results from the REFINE Trial (Scar Prevention and the Clinical Effectiveness of a Novel Mechano-modulating Polymer,) a randomised control clinical trial designed to assess the efficacy and tolerability of the Embrace(TM) device for use in the management of closed hyper-proliferative (hypertrophic and keloid) scars. This interim analysis demonstrates the efficacy of Embrace therapy within abdominoplasty (tummy tuck) - a scar-prone surgical procedure.

The results of the first 28 patients to complete the six month assessment showed a highly significant difference between the expert blinded assessments of scar appearance for the Embrace treated as compared to the control (standard-of-care treated) incision sites. All other efficacy and tolerability related parameters were strongly positive and in favor of the Embrace treatment versus that of standard-of-care, including the Patient and Observer Scar Assessment Scales (POSAS), physician and patient preference and enthusiasm to recommend and to use in the future.

Embrace Advanced Scar Therapy delivers mechano-modulation therapy to the injury site and surrounding tissues. The device includes a simple disposable applicator that transfers a predetermined level of strain to a single use adhesive silicone sheet, which is then adhered over the closed scar. This unique mechanism of action provides a uniform compressive strain, or stress-shield around a closed scar, which can minimize collagen proliferation and formation of scar tissue. The Embrace device has been FDA Cleared (September, 2011), and is being finalised for initial market release later.

Read further details here

Alzheimer's clinical trial launched

Wed, 08 Aug 2012 10:03:21 GMT

Researchers in the U.S. and Canada launched a clinical trial to evaluate deep-brain stimulation in the treatment of mild Alzheimer's disease. The study will engage 20 people, aged 55-80, with Medtronic's deep brain stimulation technology - surgically implanted devices similar to a cardiac pacemaker and that deliver electrical pulses to targeted areas of the brain.

The trial, conducted by Functional Neuromodulation Ltd., will use Medtronic's DBS therapy to target a specific area considered a "major inflow and output pathway in the brain's memory circuit."

Each patient in the study will receive the implant. Researchers will compare the effects of the implant turned on and turned off at random for a follow-up period of 12 months. Thereafter, patients with the device turned off may opt to activate their implants.

Read the full article here

Pediatric Ventricular Assist Device gains Post Approval Study

Tue, 07 Aug 2012 12:35:10 GMT

The FDA has granted approval for the Berlin Heart Goup's Post Approval Study, a condition of the "Humanitarian Device Exemption" (HDE) approval that Berlin Heart received for the EXCOR® Pediatric Ventricular Assist Device (VAD) on December 16th, 2011.

The Berlin Heart EXCOR® Pediatric VAD is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. The system is designed to support pediatric patients of all age groups and is intended to bridge patients awaiting heart transplantation from days to several months, until a donor heart becomes available. The Berlin Heart EXCOR® Pediatric VAD, which is also approved for use in Europe and Canada, is the only Ventricular Assist Device that is designed specifically for the pediatric population to be approved in the United States.

The purpose of the Post Approval Study is to evaluate whether safety and outcomes of the device in the commercial setting are comparable to the safety and outcomes of the device in the IDE study. The study will be an "all-comers" prospective study for pediatric patients who are transplant eligible, in need of mechanical circulatory support and who consent to be enrolled into the study. The study will enroll at least 39 subjects implanted with the device per device labeling, who consent to be enrolled at any implanting site with IRB approval for participation.

The Study will complete the final condition of the HDE approval. As the EXCOR® Pediatric had extensive use prior to the HDE approval (available to all North American sites who requested the device under compassionate use regulations), it is expected that the pre-approval and post-approval experience will be similar.

Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes implantable and external ventricular assist devices (VADs) for patients of every age and body size.

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Implantable defibrillators reduce cardiac arrests in North Holland

Tue, 07 Aug 2012 11:37:34 GMT

Cardiology Implantable cardioverter defibrillators account for one-third of the decrease in cardiac arrests caused by ventricular fibrillation in North-Holland, according to research in Circulation, an American Heart Association journal.

VF is an abnormal heart rhythm that makes the heart quiver so it can't pump blood. ICDs are small electronic devices implanted in the chest that detect potentially fatal abnormal heart rhythms and try to stop them with electric shocks. Generally, only people with a high risk of sudden cardiac death — mostly those at high risk of abnormal heartbeats and survivors of a previous cardiac arrest — receive ICDs.

Previous studies have shown a gradual 15-year decrease in VF-related cardiac arrests suffered outside the hospital setting — from 54 percent to 38 percent in the United States and Europe. However, the incidence of such cardiac arrests from other abnormal heart rhythms continues to increase each year. Researchers estimated that ICDs prevented 81 cardiac arrests during the 2005-2008 study. To reach this estimate, they multiplied the number of life-threatening abnormal heart rhythms stopped by an ICD by the probability that the rhythm would have led to a call to emergency medical services (EMS) and a resuscitation attempt. They assumed that a life-threatening abnormal heart rhythm would prompt calls to EMS in 62 percent of cases, and an attempt at resuscitation would occur in 67 percent of those people.

"At least one in 20 ICD carriers can expect a life-saving shock from their device each year," said Rudolph W. Koster, M.D., Ph.D., senior author and associate professor of cardiology at the Academic Medical Center in Amsterdam, The Netherlands.

Researchers used data from the Amsterdam Resuscitation Studies registry of cardiac resuscitations by EMS in the greater Amsterdam area in 1995-1997, and all EMS cardiac arrest interventions in the area in 2005-2008. Focusing on people known to have VF when EMS arrived, researchers found that an estimated 339 shocks successfully stopped 194 instances of life-threatening abnormal heart rhythms in 166 people. The percentage of patients with VF cardiac arrest fell from 63 percent in 1995-1997 to 47 percent in 2005-2008.

The annual incidence of VF cardiac arrests fell significantly, from 21.1 people per 100,000 to 17.4 people per 100,000. Incidence of cardiac arrests related to other abnormal rhythms increased significantly, from 12.2 per 100,000 to 19.4 per 100,000 annually. It's unknown what caused the other two-thirds of decline in VF arrests or why cardiac arrests vs. other abnormal heart rhythms have increased.

Read the full article here

Mechanical feeding tube declogger is cleared in U.S.

Tue, 07 Aug 2012 09:36:06 GMT

Actuated Medical has received FDA clearance for the The TubeClear system in the U.S. The medical device unclogs feeding and decompression tubes without having to disconnect them from patients.

Feeding tubes are renowned for clogging and and removing them from patients for cleaning can be uncomfortable for patients and may complicate matters for clinicians. The system uses single use clearing stems connected to a control box to access the blockage and mechanically remove it from the tube.

Actuated Medical describes the device as fast, effective and at least seven times faster than current approaches. It enables feeding and medication regimens to be quickly reinstated without removing and replacing tubes, saving on resources.

In addition to the newly approved system for NG tubes, two new TubeClear control boxes as well as clearing tubes for Nasoenteric (nENT), Percutaneous Endoscopic Gastronomy (PEG) and Gastrostomy-Jejunostomy (GJ) tubes are currently pending 510(k) clearance with the FDA.

TubeClear is also CE Marked and is available throughout Europe, the Middle East and North Africa.

Read the full story here

Harvard develops pressure sensitive smart drill

Tue, 07 Aug 2012 09:54:37 GMT

A lab tour at Harvard demonstrated some interesting technologies that scientists and engineers are working on. This inculded a Cranial Drilling Device with Retracting Drill Bit After Skull Penetration. As the name implies, the bit recedes back into the housing once pressure on its tip drops, preventing it from entering the soft tissue of the brain.

Currently, drilling is typically done with a hand-cranked device that surgeons are trained to safely operate. The new tool should help increase safety while speeding up the drilling process, and perhaps may lend itself to use by non-neurosurgeon clinicians for performing trepanations for intracranial pressure monitoring and other uses.

Read the full article here

New brace aims to delay knee replacment surgery

Mon, 06 Aug 2012 10:43:39 GMT

DLO Global's OA nano is the lightest knee brace of its kind in the world and the device manufacturer anticipates that more knee pain or osteoarthritis sufferers can use the brace to forgo total knee replacement surgery, possibly for years.

The brace can be worn for between 6 to 10 hours a day and has been designed so that it can be worn onobtrusively beneath clothing. Its structure is similar to devices used by professional athletes, featuring patented technology that provides support and stability for the knee. The OA Nano has reduced bulk and weight so that it appeals to a wider audience.

Read the full article here

Positive trial results for needle free transdermal glucose monitoring device for critical care patients

Mon, 06 Aug 2012 09:15:57 GMT

This was the second of 2 clinical trials for the Echo Therapeutics' Symphony system.

The study was undertaken at Thomas Jefferson University Hospital. It enrolled 15 adult patients in critical care settings undergoing major general surgery and cardiothoracic surgery. Blood samples were taken from arterial line catheters at 30-minute intervals and measured on a YSI 2300 STAT Plus Glucose Analyzer. 1,200 Symphony tCGM glucose readings were taken. The device’s error rate was 9 percent and a Continuous Glucose-Error Grid analysis showed that 98.9 percent of the readings were clinically accurate, according to the statement.

Echo Therapeutics plans to meet with the European regulatory authorities and the U.S. Food and Drug Administration and will seek CE Mark approval in Europe before completing a pivotal trial and filing for FDA approval.

Read more here

DePuy synthes spine systems approved to treat scoliosis

Mon, 06 Aug 2012 10:25:25 GMT

DePuy Synthes Spine has received 510(k) clearance from the FDA for use of its EXPEDIUM, VIPER and VIPER2 Spine Systems on patients with adolescent idiopathic scoliosis.

The EXPEDIUM technology was introduced in 2004. The VIPER and VIPER2 Spine Systems have been used in minimally invasive spine surgery for a wide range of pathologies since 2005 and 2008, respectively.

The approval paves the way for the devices to be used in posterior non-cervical pedicle screw fixation in adolescent patients and for DePuy to provide training and education about its appropriate use.

Read more here

Vascular access catheter gains CE mark

Thu, 02 Aug 2012 10:52:40 GMT

Semprus BioSciences, a subsidiary of Teleflex, has received the CE mark for the Nylus peripherally inserted central catheter. The device uses a polymer designed to reduce the attachment of platelets and blood proteins at its surface. In-vitro and animal testing of the catheyer has shown to reduce platelet adhesion and thrombus accumulation.

The device aims to reduce infection and thrombus-related complications for patients.

Read more here

New device reduces blood loss during orthopaedic surgery

Thu, 02 Aug 2012 10:37:06 GMT

Medtronic has received FDA clearance for its new Aquamantys3 BSC 9.1S Bipolar Sealer with Cutting. The device performs haemostatic sealing and coagulation of soft tissue and bone and allows the surgeon to use it as a cutting instrument as well.

Bringing two tools into one and not having to switch between instruments while the blood is flowing saves on time for the surgeon. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased hospital ength of stay.

Like other devices in the Aquamantys line, the new device combines radiofrequency energy and saline that has been shown to reduce blood loss and maintain patient hemoglobin levels when used during orthopaedic procedures.

Read more here

FDA approves 'smart pill'

Thu, 02 Aug 2012 09:49:28 GMT

The Ingestion Event Marker from Proteus Digital Health had been approved by the FDA. The ingestible sensor can transmit information on medication adherence and the patient's vital signs to medical professionals.

The sensor is about the size of a grain of sand and made from silicon and ingredients found in food. It can be embedded in a pill and when swallowed, fluids in the stomach activate the sensor to communicate a signal to a wearable patch that marks the timing of ingestion. The battery-operated patch can also measure heart rate, temperature and activity but needs to be changed every seven days.

Data collected by the sensors is relayed to a mobile phone application where it can be accessed by caregivers and clinicians. The system was tested in areas including tuberculosis, mental health, heart failure, hypertension and diabetes. Patients taking medication for diabetes, central nervous system disorders and immune suppression after organ transplant are potential targets for the device.

The Ingestion Event Marker took four years to gain FDA approval. It achieved the CE Mark in 2010 and the company rolled out its first application in Europe with LloydsPharmacy earlier this year.

Find out more medcitynews.com/2012/07/fda-clears-first-smart-pill-that-senses-when-its-been-taken/

New thrombectomy device offers relief to ischemic stroke patients

Mon, 30 Jul 2012 14:17:45 GMT

'ReCover', one of the latest devices from Campbell CA based Lazarus Effect, may offer relief to over 2 million people in Europe who become stroke patients, each year. Some 78% of stoke cases are ischemic, occuring when the blood supply to the brain is blocked.

ReCover features a stent-based clot retriever with an integrated nitinol mesh protective segment that automaticallycovers ansd protects the thrombus as the device is removed, helping to prevent clot fragmentation or embolism and secondary stroke which commonly occur during thrombectomy procedures. The device integrates protection directly onto a proven stent retriever design and could reduce the number of devices needed in thrombectomy procedures.

ReCover will be presented at the Society for Neurointerventional Surgery (SNIS) Annual Meeting in San Diego. Recent CE Mark approval paves the way for the launch of ReCover throughout the continent, in 2013. It is one of a range of Lazarus Effect products designed for treating ischemic stroke which makes use of patent-pending wire-frame technology.

Read more here

Nano sized laser not visible to the human eye is developed

Mon, 30 Jul 2012 12:46:07 GMT

The ultra nano device is hailed as a breakthrough for emerging photonic technology for applications ranging from computing to medicine. Scientists from the University of Texas at Austin along with colleagues in Taiwan and China have developed an ultra tiny semiconductor laser which is not even visible to the human eye. The nano laser is regarded as key for the development of faster, smaller and lower energy photon-based technologies which includes highly sensitive biosensors for detecting, treating and studying disease.

Until now, the size and performance of photonic devices have been restricted by the three-dimensional optical diffraction limit; the new laser device operates below this level. The current research paper reports on the first operation of a continuous-wave, low-threshold laser below the 3-D diffraction limit.

The device is constructed from a gallium nitride nanorod which holds indium gallium nitride. Both alloys are semiconductors used commonly in LEDs. The nanorod is placed on top of a thin insulating layer of silicon that covers a layer of film which is smooth at the atomic level. The sientists have been perfecting the material for over 15 years and it is the smoothness that prevents photonic devices from losing waves of electrons.

Read more here

Bioabsorbable screws associated with lower rate of complications in treatment of intra-articular calcaneal fractures

Wed, 25 Jul 2012 10:57:48 GMT

Research reported in the February issue of the Journal of Trauma and Acute Care Surgery, has suggested that treatment of intra-articular calcaneal fractures with bioabsorbale screws may present advantages in clinical outcomes compared to stabilization with plates and absorbale screws.

In a prospective, randomized study, 97 patients undergoing treatment for intra-articular calcaneal fractures between February 2007 and March 2009 were assigned to two groups: 52 cases receiving treatment with plates (group A) and 47 cases with absorbale screws (group B). Clinical outcomes and incicidence of complications were subsequently assessed and compared using the adjusted American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (subjective component only), Foot Function Index, and the calcaneal fracture scoring system, at an average follow-up time of 23 months.

Results showed no incidence of nonunion in either group. One year post-operative outcomes were reported as follows:

mean adjusted American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score: group A: 71.6 ± 12.5, group B: 72.3 ± 17.4 (p > 0.05)

mean Foot Function Index score: group A: 21.4 ± 6.6, group B: 22.7 ±5.2 (p > 0.05)

mean calcaneal fracture scoring system score: group A: 73.5 ± 8.3, group B: 75.1 ± 6.9, (p >0.05)

In terms of complications, the patient group treated with plates reported six cases of poor wound healing, one case of deep infection, and four cases of peroneal tendon irritation. Of those patients receiving fracture stabilization treatment with absorbable screws, only one case of superficial infection, and no deep infection and soft tissue irritation was reported.

Although these results show that outcomes of operative treatment with absorbable screws and outcomes of operative treatment with plates are comparable, with both groups presenting favourable results as surgical tratment options for calcaneal fractures, the study does suggest that metalic plate treatment is associated with a higher risk of complications. Fracture stabilization with bioabsorbale screws presents the advantages of lower complication rates and avoids the need for screw removal.

Find out more via the Journal of Trauma and Acute Care Surgery study 'A comparison of absorbable screws and metallic plates in treating calcaneal fractures: a prospective randomized trial'.

Stryker issues voluntary recall for Rejuvenate and ABG II modular-neck stems

Tue, 10 Jul 2012 16:09:17 GMT

Global medical device manufacturer Stryker has issued a voluntary recall for two of its metal-on-metal hip implant components, the Rejuvenate and ABG II modular-neck stems. The decision to opt for a voluntary recall has been taken following evidence of less-than-positive post-market surveillance results, which, according to the Stryker website, reveal the Rejuvenate and ABG II components to exhibit "a potential for fretting and corrosion at the modular neck junction which may lead to adverse local tissue reactions". Stryker will continue to evaluate post-market surveillance data for the two components. The manufacturer's monolithic stems are not part of this voluntary recall.

Find out more about the voluntary recall from Stryker here.

Study examines use of irreversible electroporation procedure to treat perivascular hepatic malignant tumours

Fri, 06 Jul 2012 15:00:16 GMT

A recently published retrospective review of outcomes for patients treated with the Angiodynamics NanoKnife system has yielded promising results when used in ablation procedures to treat perivascular hepatic malignant tumours. The review, which was published online in the Journal of the American College of Surgeons (19/06/2012), examines results from 28 patients treated with the NanoKnife device between January 1 and November 2 2011, in surgical interventions targetting a total of 65 pervivascular tumours.

Patient selection for treatment with the irreversible electroporation (IRE) procedure, performed using the NanoKnife system, was considered when resection or thermal ablation was not indicated due to tumour location, and treatment outcomes were classified by local, regional, and systemic recurrence and complications. Evalutation with post-operative imaging was used to assess blood vessel condition adjacent to the treatment sites of the tumours. Of the twenty eight patients selected, twenty two (79%) were treated via an open approach and 6 (21%) were treated percutaneously. Median tumour size was 1 cm (range 0.5 to 5 cm). Twenty five tumours were <1 cm from a major hepatic vein; 16 were <1 cm from a major portal pedicle. Additionally, prior to the procedure all patients were judged to have locally advanced pain (median pain score of five on a scale of three to nine), taking a median dose of 75 mcg narcotics per day.

The authors of the study reported encouraging results for the NanoKnife System, and concluded that from early analysis the device demonstrates safety and positive short-term outcomes for the treatment of perivascular hepatic malignant tumours. At an average follow-up of six months, 96% of patients revealed no persistent disease, and 95% of tumours had not recurred locally. Additionally, average patient narcotic use had fallen to 25 mcg per day with median pain score recorded as three. There was no incidence of treatment-associated mortality and an overall morbidity rate of 3%. Complications included one intraoperative arrhythmia and one occurrence of postoperative portal vein thrombosis.

Although the NanoKnife low-energy direct current (LEDC) thermal ablation system has not been cleared for the treatment or therapy of any specific disease or condition, the device has received US Food and Drug Agency (FDA) 510K approval for use in the surgical ablation of soft tissue.

Read more in the original Journal of the American College of Surgeons article 'Ablation of Perivascular Hepatic Malignant Tumors with Irreversible Electroporation'.

Find out more about the NanoKnife device here.

CPT stem demonstrates excellent results at 15 years follow up

Sun, 01 Jul 2012 16:49:15 GMT

In the debate about new technologies in hip replacement, it is important to remember the effectiveness of older implants: cemented polished tapers do very well. In a 15 year follow up study of Zimmer’s CPT implant published in this month’s Journal of Bone and Joint Surgery, the 16 year survivorship with re-operation for any reason was 80.7%. Only one of the original 191 stems was revised for aseptic loosening at a mean of 15.9 years. The mean age of patients at operation was 64.5 years (21 to 85).

Reference

Burston BJ, Barnett AJ, Amirfeyz R, Yates PJ, Bannister GC. Clinical and radiological results of the collarless polished tapered stem at 15 years follow-up. J Bone Joint Surg Br. 2012 Jul;94(7):889-94.

Study aims to compare stent apposition rates in STENTYS Self-Apposing Stent and Medtronic Resolute drug-eluting stent

Wed, 27 Jun 2012 11:34:42 GMT

A prospective, randomized, multi-center study comparing stent apposition in patients suffering from ST-elevation Myocardial Infarction has been launched this month by medical device manufacturer STENTYS.

The APPOSITION IV study will recruit 150 heart attack patients into two treatment groups: patients treated with the STENTYS Self-Apposing Stent and those receiving therapy with Medtronic's Resolute drug-eluting stent. The results - a comparison of stent apposition rates at four or nine months post-treatment - are expected to be announced in 2013.

Stent malapposition has previously been noted as a potential risk of conventional drug-eluting stent usage. Linked to occurrences of stent thrombosis and subsequent adverse clinical events including stent re-clotting, recurrence of heart attack and possible eventual death, the potential to improve apposition rates would be highly desirable to Cardiologists considering therapeutic options for the treatment of acute myocardial infarction.

STENTYS are hopeful that the new Self-Apposing Stent will significantly reduce, or eliminate, the risk of stent malapposition by fitting snugly to the blood vessel contour and then adapting to anatomic changes in the arteries during the post-infarction phase. STENTYS hopes to gain CE mark status for this device in 2014.

Find out more about the Medtronic Resolute stent here.

Fewer 'unnecessary' shocks with Cameron Health's S-ICD defibrillator

Fri, 22 Jun 2012 13:08:02 GMT

Data obtained from an ongoing clinical trial (the EFFORTLESS study), has revealed a 50% reduction in incidence of inappropriate shocks delivered by Cameron Health's under-the-skin defibrillator since the device gained FDA circulatory devices panel recommendation in April this year.

The study, reported at the recent Cardiostim conference in France, reveals that the incidence of unnecessary shocks delivered by the S-CID has halved to 7%, a result thought to be attributable to the longer cardiac event response times of the Cameron Health S-ICD in comparison to standard implantable cardiac defibrillators. Yet while Cameron's S-ICD delivered response times of longer than 18 seconds in 12% of the 219 cases studied, it always responded in time when life-saving therapy was needed, discharging shock for abnormal heart rhythms reversal in 100% of cases.

Dr Gust Brady, credited with the invention of the Cameron Health S-ICD, also believes that the improved rate of unnecessary shocks may be due to improved clinician understanding of the device. Dr Brady suggests that in previous clinical trials, the device may have been implanted in patients with heart rhythms outside of the preferred pattern recommended by the manufacturer, leading to false-positive shocks. Failure to effectively define the types of rhythms the device should consider dangerous through ineffective clinician programming of the S-ICD's shock zones is another probable cause of previous inappropriate shock occurrence.

More information about the ongoing Cameron Health Post Market S-ICD Registry (EFFORTLESS) study is available here.

Rate, review and find out more about the Cameron Health S-ICD here.

St Jude Medical's Amplatzer Vascular Plug 4 granted FDA approval

Wed, 20 Jun 2012 10:24:16 GMT

The Amplatzer Vascular Plug 4 from St Jude Medical has now received US Food and Drug Administration (FDA) clearance and will be launched immediately on the US market. The Amplatzer Plug is designed for use in transcatheter embolization procedures within the peripheral vasculature, with the Vascular Plug 4 model setting precedent as the first in the industry that can be delivered using a standard diagnostic catheter. Eliminating the need for catheter exchanges will lead to a simplification of the peripheral embolization procedure and more efficient means of blocking or redirecting blood flow through the peripheral vessels than with alternative surgical clips or embolic coils.

For more information on the Amplatzer Vascular Plug 4 click here.

Vena cava filters do not lower mortality rate in many pulmonary embolism cases

Fri, 15 Jun 2012 13:21:42 GMT

A series of three papers published in the May 2012 edition of the American Journal of Medicine aims to shed new light on the efficacy of vena cava filters used in the treatment of pulmonary embolism.

The findings, based on a study of the Nationwide Inpatient Sample, a government database of more than two million patients treated for pulmonary embolism between 1999 and 2008, indicate that vena cava filter placement does not improve mortality rates in the majority of cases.

The second article of the series, however, does highlight that for the small percentage of patients suffering pulmonary embolism who arrive at hospital in an unstable condition - in shock or requiring a ventilator – vena cava filters do significantly improve mortality rates. In addition to treatment with vena cava filters, it is also essential that these patients also receive thrombolytic therapy, according to the third paper in the publication series.

The research, published by Paul Stein of Michigan State University, should help to form clearer guidance on the treatments that are most effective for pulmonary embolism patients.

For full details of the three studies link out to the American Journal of Medicine articles below:

Impact of Vena Cava Filters on In-hospital Case Fatality Rate from Pulmonary Embolism

Case Fatality Rate with Pulmonary Embolectomy for Acute Pulmonary Embolism

Thrombolytic Therapy in Unstable Patients with Acute Pulmonary Embolism: Saves Lives but Underused

Rate, review and compare a range of vena cava filters here

Study shows benefit of acellular human dermal matrix in rotator cuff repair

Mon, 11 Jun 2012 09:13:19 GMT

In a prospective randomised study, researchers used GraftJacket acellular human dermal matrix to augment rotator cuff repairs of greater than 3cm. Results were better in the augmented group at a mean of 24 months of follow up, and there were more intact cuffs seen on MRI. The team from Plano Orthopaedic Centre in Texas reported no adverse effects.

Barber FA, Burns JP, Deutsch A, Labbé MR, Litchfield RB. A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair. Arthroscopy. 2012 Jan;28(1):8-15. Epub 2011 Oct 5.

Updated checklist for anaesthetic equipment published

Sun, 10 Jun 2012 07:31:13 GMT

The Association of Anaesthetists of Great Britain and Ireland (AAGBI) have issued an updated version of guidance for checking anaesthetic equipment, following discussion with the UK MHRA and the National Patient Safety Agency. The new guidance aims to be applicable to any machine and emphasises outcomes rather than processes.

To read the full version of the guidance look here.

To read the MHRA alert look here.

Intramedullary nail has similar results to sliding hip screw for trochanteric fractures

Fri, 08 Jun 2012 07:49:44 GMT

In a randomised controlled study of 598 patients with 600 hip fractures, Parker et al from Peterborough demonstrated very similar outcomes when comparing a sliding hip screw with a Targon PF nail in terms of surgical complications and the need for blood transfusion. Intramedullary nails took slightly longer in theatre, needed more radiological screening time, but patients had a tendency to a better return of mobility compared with sliding hip screws.

Parker MJ, Bowers TR, Pryor GA. Sliding hip screw versus the Targon PF nail in the treatment of trochanteric fractures of the hip: a randomised trial of 600 fractures. J Bone Joint Surg Br. 2012 Mar;94(3):391-7.

Studies show contrasting results for platelet-rich-plasma (PRP) therapy

Thu, 07 Jun 2012 13:54:20 GMT

In a randomized controlled study from the Hospital for Special Surgery Rodeo et report that platelet rich fibrin matrix (PRFM) had no beneficial effect on rotator cuff healing. The authors used PRFM (Cascade Autologous Platelet System, Musculoskeletal Transplant Foundation, Edison, New Jersey) in patients of 40 years or older who had failed non operative treatment for full thickness rotator cuff tear. The system forms fibrin matrix by activation of the fibrin - clotting cascade using nine mls of peripheral venous blood. Cuff repairs were assessed with ultrasound at six and 12 weeks postoperatively. The authors comment that PRFM may have had a negative effect on healing.

In another study in the same journal, de Almeida et al report a smaller randomised study in which patients who underwent patellar tendon harvest had platelet-rich plasma (PRP) applied to the central patellar tendon defect. The authors used a Haemonetics MCS+ cell separator with a specific kit for platelet apheresis (995-E) and showed a smaller gap in the patellar tendon in treated patients.

Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012 Jun;40(6):1234-41. Epub 2012 Apr 10.

de Almeida AM, Demange MK, Sobrado MF, Rodrigues MB, Pedrinelli A, Hernandez AJ. Patellar tendon healing with platelet-rich plasma: a prospective randomized controlled trial. Am J Sports Med. 2012 Jun;40(6):1282-8. Epub 2012 Apr 2.

DES surface changes during balloon expansion reported in Journal of American Medical Association research letter

Tue, 05 Jun 2012 11:58:56 GMT

In a research letter published in the May 23/30, 2012 issue of the Journal of the American Medical Association (JAMA), it has been hypothesised that the polymer surface of drug-eluting stents (DES) may become damaged during delivery balloon expansion, and that microparticles may detach. DES surface damage ranging from deformation (ridging, cracking, peeling, or webbing) to complete delamination could lead to potential DES-associated complications, including thrombosis, restenosis, and microvascular and endothelial dysfunction.

In a preliminary study of 4 FDA approved DESs (the Abbott Laboratories Xience V, the Boston Scientific Taxus Liberté, the Cordis Cypher, and Medtronic's Endeavor), a sample of 5 stents from each manufacturer were tested in a vacuum filtration system containing a filtered test medium. A bare metal stent was also used for control purposes. Although each stent was expanded unconstrained, the study was otherwise conducted under conditions mimicking those required for regulatory submission and across the range of conditions required to mirror the variability encountered in clinical practice. Results were pooled across conditions, as no significant differences were noted between the various expansion conditions for each particular DES.

Results of this preliminary study reveal that the median proportion of total surface damage occurring during balloon expansion was associated with polymer type and involved both adluminal and abluminal surfaces. The dimensions of damage and of detached microparticles ranged from 2 to 350 μm. and the extent of damage differed by manufacturer.

The study concludes that further research would be useful to confirm these findings and to further investigate the physiological and clinical consequences of polymer damage and microparticle detachment.

For a full account of this study, read the JAMA research letter 'Changes to Polymer Surface of Drug-Eluting Stents During Balloon Expansion' by J Scott et al.

DNA nanoparticles reduce joint inflammation

Sun, 27 May 2012 18:06:00 GMT

In a study published in the Journal of Immunology, researchers from the Georgia Health Sciences University have demonstrated that nanoparticles designed to deliver nucleic acids into cells and tissues were able to reduce inflammation in joints by virtue of their presence alone. The nanoparticles overcame the immune stimulation used in the mouse model without the additional nucleic acids they were designed to deliver. The team have work to do to identify the best polymer to use clinically, but this study suggests there is potential for development of a new class of medical device.

Reference

Huang L, Lemos HP, Li L, Li M, Chandler PR, Baban B, McGaha TL, Ravishankar B, Lee JR, Munn DH, Mellor AL. Engineering DNA Nanoparticles as Immunomodulatory Reagents that Activate Regulatory T Cells. J Immunol. 2012 May 15;188(10):4913-20. Epub 2012 Apr 18.

Study shows low linear wear rate in hips with X3 crosslinked polyethylene

Tue, 22 May 2012 18:48:32 GMT

In a prospective multicentre study D’Antonio et al followed 167 hips in 155 patients and measured linear wear at up to 5 years. Patients received the Stryker Secur-Fit stem, a Trident acetabular socket, a 32mm head and a 0 degree X3 liner. The average wear rate was 0.015mm per year over 5 years and was tolerant of different cup inclinations, although one outlier with a 72 degree cup inclination had increased wear. The authors state this is a 58% improvement over historical controls.

D'Antonio JA, Capello WN, Ramakrishnan R. Second-generation Annealed Highly Cross-linked Polyethylene Exhibits Low Wear. Clin Orthop Relat Res. 2012 Jun;470(6):1696-704. Epub 2011 Dec 9.

Lumax 740 ICD range receives FDA approval

Mon, 21 May 2012 15:33:51 GMT

The Lumax 740 ICD portfolio from Biotronik has recently received approval from the U.S. Food and Drug Administration (FDA). The Lumax 740 range of implantable cardioverter defibrillators incorporates a range of device design features to help clinicians monitor patients, and is indicated as safe to undergo MRI scans in certain conditions. Lumax 740 ICD devices have already been approved by European regulators (November 2011).

Find out more about the Lumax 740 ICD here.

Benefit of fixed or mobile bearing knee replacement depends on age

Sun, 20 May 2012 18:07:37 GMT

In a double blind randomised trial by Jolles et al from the University of Lausanne reported in this month’s Journal of Bone and Joint Surgery, patients undergoing NexGen LPS knee replacement were randomised to either the fixed or mobile bearing variants. Assessment using gait analysis at up to 5 years demonstrated better function for mobile bearing knees in patients under 70 years, and for fixed bearing knees in patients over 70 years. Although this is a small study which requires further validation, it suggests that the choice of mobile or fixed bearing knee might depend on the age of the patient.

Jolles BM, Grzesiak A, Eudier A, Dejnabadi H, Voracek C, Pichonnaz C, Aminian K, Martin E. A randomised controlled clinical trial and gait analysis of fixed- and mobile-bearing total knee replacements with a five-year follow-up. J Bone Joint Surg Br. 2012 May;94(5):648-55.

Impact sports reduce the longevity of hip replacements

Thu, 17 May 2012 10:14:10 GMT

Returning to impact sports such as jogging, soccer or martial arts is a goal for some patients after total hip arthroplasty, but the effect of this on longevity of the implant is poorly understood. In a review of 70 patients who had undergone total hip arthroplasty published in Clinical Orthopaedics this month, Ollivier et al have demonstrated higher hip scores, but also higher linear wear and a higher revision rate in patients undertaking impact sports compared to controls. At 15 years, survivorship was 80% (74% to 86%) in the high impact group, and 93.5% (88.2% to 97.6%) in the controls.

Patients received the Symbios cementless HA coated stem, a cementless hydroxyapatite coated acetabular component with conventional polyethylene and a 28mm ceramic head.

Reference

Ollivier M, Frey S, Parratte S, Flecher X, Argenson JN. Does Impact Sport Activity Influence Total Hip Arthroplasty Durability? Clin Orthop Relat Res. 2012 Apr 25. [Epub ahead of print]

Ellipse ICD receives FDA approval

Wed, 16 May 2012 13:59:32 GMT

The Ellipse ICD, manufactured by St. Jude Medical has recently received approval from the U.S. Food and Drug Administration (FDA). The new implantable cardioverter defibrillator is the smallest high-voltage ICD available in the industry and has already been approved by European regulators.

Find more information on the Ellipse ICD here.

Wii-hab as good as physiotherapy after cruciate ligament reconstruction

Mon, 14 May 2012 09:52:50 GMT

In a prospective randomised double-blind study, researchers from the Hacettepe University, Ankara have demonstrated that using wii-sports after anterior cruciate ligament reconstruction is as good as conventional rehabilitation. The team randomised thirty volunteer patients to 12 week programmes comprising standard rehabilitation or Wii-hab including the balance board and Wii Sports and Sports Pro games. Participants were indistinguishable on measures of knee strength, balance and functional squat tests at the first, 8th and 12th weeks postoperatively.

Reference

Baltaci G, Harput G, Haksever B, Ulusoy B, Ozer H. Comparison between Nintendo Wii Fit and conventional rehabilitation on functional performance outcomes after hamstring anterior cruciate ligament reconstruction: prospective, randomized, controlled, double-blind clinical trial. Knee Surg Sports Traumatol Arthrosc. 2012 Apr 29. [Epub ahead of print]

Access the full summary of this study here.

View a range of devices designed for use in knee procedures here.

Study demonstrates lower wear rates in highly cross-linked polyethylene bearings in hip replacement in under 65s

Fri, 11 May 2012 15:15:47 GMT

Adding to the debate about bearing surfaces, a team from St Michael’s Hospital in Toronto studied 102 hip replacements in 91 patients randomised to receive either a cobalt-chrome on ultra-high molecular weight polyethylene (UHMWPE), cobalt chrome on highly cross-linked polyethylene (HXLPE), or a ceramic-on-ceramic bearing. All patients received a Smith and Nephew Synergy uncemented stem and a Reflection uncemented acetabular component. Bearings were 28mm cobalt-chrome heads with UHMWPE, HXLPE or ceramic-on-ceramic. 87 patients were available for five year review.

The team found no differences in outcome scores or failure rates, but did find a significant difference in mean polyethylene wear rates; 0.151 mm/year for UHMWPE compared with 0.059mm/year for HXLPE. The ceramic-on-ceramic bearing wear was less at 0.0067mm/year, but 3 of 34 patients had squeaking of the bearing.

For more information on this study, please refer to the Journal of Bone and Joint Surgery (British Volume) article by VS Nikolaou et al here.

Study finds no evidence that hip resurfacing leads to better outcomes than total hip arthroplasty at one year

Sat, 05 May 2012 15:29:46 GMT

The BMJ continues to demonstrate its interest in metal on metal hip replacements by publishing a study from Costa et al of Warwick University (1). 126 patients thought suitable for hip resurfacing were randomised either to hip resurfacing or total hip arthroplasty. Outcomes at one year measured by Harris hip score and Oxford hip score were not significantly different between the groups. However, this was a pragmatic study comprising a number of different implants and surgeons and the confidence intervals for this result were wide. It has become clear that not all hip resurfacing devices are the same.

Other authors have noticed a greater improvement in quality of life scores (SF36) and WOMAC scores in patients who have had resurfacing compared to total hip replacement (2,3).

(1) Costa ML, Achten J, Parsons NR, Edlin RP, Foguet P, Prakash U, Griffin DR; Young Adult Hip Arthroplasty team. Total hip arthroplasty versus resurfacing arthroplasty in the treatment of patients with arthritis of the hip joint: single centre, parallel group, assessor blinded, randomised controlled trial. BMJ. 2012 Apr 19;344:e2147. doi: 10.1136/bmj.e2147.

(2) The Alberta Hip Improvement Project. Functional Outcomes for 2 Years Comparing Hip Resurfacing and Total Hip Arthroplasty. J Arthroplasty. 2012 May;27(5):750-757.e2. Epub 2012 Jan 28.

(3) Lingard EA, Muthumayandi K, Holland JP. Comparison of patient-reported outcomes between hip resurfacing and total hip replacement. J Bone Joint Surg Br. 2009 Dec;91(12):1550-4.

CABG more effective than PCI in treatment of non-emergency multi-vessel coronary disease in older patients

Thu, 03 May 2012 16:26:06 GMT

A collaborative observational study undertaken by the American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) compares the effectiveness of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG) in the treatment of older patients with two- or three-vessel coronary artery disease not requiring emergency treatment.

The study, which links data from the ACCF National Cardiovascular Data Registry and the STS Adult Cardiac Surgery Database, to claims data from the Centers for Medicare and Medicaid Services, compares long-term survival rates in 86,244 patients aged 65 or over who have undergone CABG surgery and 103,549 patients receiving PCI treatment. While there is no reported significant difference in adjusted mortality rates between the two groups at the 1 year follow-up mark, at 4 years patients treated with CABG reveal lower rates of mortality compared to those who have undergone PCI (16.4% vs. 20.8%; risk ratio, 0.79; 95% CI, 0.76 to 0.82). Similar findings were noted with several different methods of analysis and in multiple patient subgroups.

To access the full New England Journal of Medicine summary of this study, click here.

Compare a range of devices used in coronary intervention procedures here.

Smoking linked to joint replacement failure

Tue, 01 May 2012 12:58:23 GMT

Two new studies presented at the American Academy of Orthopaedic Surgeons (AAOS) 2012 Annual Meeting reveal the damaging effects of smoking on total joint replacement.

The first, an analysis of 621 patients undergoing total knee replacement (TKR) procedures, assessed clinical outcomes including pain, function and range of motion, in smokers and non-smokers. Of the group of smokers, knee replacement failure rate was 10 times higher than in those classed as non-smokers. The rate of additional medical complications including DVT, blood clots, anaemia requiring treatment, cardiac problems and acute renal failure was also revealed to be 'significantly higher' in smokers.

The second study investigated the effects of smoking on patients undergoing acetabulum reconstruction surgery using ultra-porous metal. Generally, these newer materials have shown a tendency to lead to fewer hip replacement failures and higher survival rates than implants made from standard porous metals. In this study of 533 hip replacements (159 primary and 374 revision surgeries) a failure rate of 9.1% was recorded in smokers, compared to the 3.4 % observed in non-smokers.

More information on these studies and the related AAOS Smoking Cessation Forum can be found here.

View devices used in knee replacement procedures here.

View a range of acetabular components here.

Lancet study reveals lower rates of stent thrombosis with cobalt-chromium everolimus eluting stents

Sun, 29 Apr 2012 13:10:04 GMT

A network meta-analysis of randomised controlled trials comparing different drug-eluting stents, or drug-eluting with bare-metal stents, has revealed that cobalt-chromium everolimus eluting stents (CoCr-EES) deliver the lowest rate of stent thrombosis within two years of implantation.

The 49 trial sample analysis includes results from more than 50,000 patients and revealed a number of findings. The incidence of 1-year definite stent thrombosis was significantly lower with CoCr-EES than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13—0·41). The significant difference between these stent classes was evident from as early as 30 days, and also in the 31 day - 1 year period. CoCr-EES were also linked to significantly lower rates of 1-year definite stent thrombosis When compared with paclitaxel-eluting stents, permanent polymer-based sirolimus-eluting stents, phosphorylcholine-based zotarolimus-eluting stents, and Resolute zotarolimus-eluting stents.

No other drug-eluting stent had lower definite thrombosis rates compared with bare-metal stents at 2-year follow-up.

The full summary of this study can be found here.

Compare Which Medical Device listings for drug eluting stents here.

Stryker Mitch/Accolade total hip replacement should no longer be used

Sun, 22 Apr 2012 16:56:31 GMT

Ongoing concerns about metal-on-metal hip bearings have continued with the issue of a UK MHRA alert about the combination of the Stryker Mitch large metal-on-metal bearing with the Accolade stem. Analysis of the England and Wales National Joint Registry data has demonstrated a revision rate of 8.8% at 4 years for all Mitch/femoral stem combinations which is higher than the NICE benchmark. Interestingly, revision rates with the uncemented Accolade stem were substantially worse than with the cemented Exeter stem (4 year revision rate 10.7% compared with 3.7%).

The Mitch resurfacing has a lower revision rate of 3.1% at 4 years, which is in line with NICE guidance.

The Mitch bearing is manufactured by Finsbury Orthopaedics, which was acquired by DePuy in 2009.

MHRA alert: air or gas-pressurised spray devices for application of sprayable fibrin sealants in intra-operative haemostasis

Wed, 11 Apr 2012 17:12:40 GMT

The MHRA has issued a medical device alert for air- and gas-pressurised spray devices used in the application of sprayable fibrin sealants for intra-operative haemostasis.

The MHRA warns of a risk of life-threatening or fatal embolism occurring in patients during, or immediately after, application of fibrin sealants via air- or gas-pressurised spray devices. According to the MHRA, those adverse advents reported seem to be linked to use of the spray device in conditions not endorsed by the manufacturer: either at a greater pressure setting, or closer to the tissue surface, than recommended.

Devices currently available in the UK which may be affected by this issue:

Evicel Fibrin Sealant (human) and spray device (Omrix Pharmaceuticals)
Quixil Fibrin Sealant (human) and spray device (Omrix Pharmaceuticals)
Tisseel Lyo Fibrin Sealant and Tisseel ready to use Solutions for Sealant (Baxter Healthcare) when used with EasySpray application devices (Baxter Healthcare)

Read the official MHRA alert including recommended actions for medical practitioners using this device here.

View more information on tissue products used with fibrin sealants here.

Lancet study reveals high failure rate in stemmed metal-on-metal hip replacements

Tue, 03 Apr 2012 09:54:46 GMT

A new Lancet study provides analysis of hip replacement failure rates in relation to prosthesis head size, using data collected from National Joint Registry of England and Wales records of primary hip replacements undertaken between 2003 and 2011. The study, based on an analysis of 402 051 primary hip replacements (31 171 of which stemmed metal-on-metal) concludes that stemmed metal-on-metal THRs fail at high rates, with larger heads failing earlier.

Click here to access the complete abstract of this Lancet study (please note, a Lancet subscription or one-off payment is required in order to access the full article).

Related news and editorials

New MHRA alert for metal-on-metal hip replacements (28th February 2012)

Editorial: navigating the narrow straits of device regulation (7th February 2012)

NICE publishes guidance on use of the PleurX Catheter Drainage System for patients with treatment-resistant recurrent malignant ascites

Wed, 28 Mar 2012 14:28:29 GMT

The National Institute for Health and Clinical Excellence (NICE) has recently published final guidance supporting use of the PleurX catheter system from CareFusion. The report suggests that the catheter drainage system could help improve patients’ quality of life, reduce complications and result in significant financial savings for the NHS.

The assessment, carried out through NICE’s Medical Technology Evaluation Program, concluded that the PleurX system should be considered for use in all patients with treatment-resistant recurrent malignant ascites.

The PleurX catheter drainage system is inserted into a patient’s abdominal space and enables fluid build-up to drain out into a vacuum bottle. This process can be carried out by the patient, in their own home, potentially eliminating as many as 15 days per month of additional hospital-based treatment for those requiring such fluid drainage procedures.

Access a PDF of the NICE guidance document 'PleurX peritoneal catheter drainage system for vacuum assisted drainage of treatment-resistant recurrent malignant ascites' here.

Find out more about the PleurX catheter drainage system from CareFusion here.

Endovascular Repair Effective for Inflammatory AAA

Thu, 01 Mar 2012 14:11:49 GMT

A study, reported in Cardiology News (28/02/2012) suggests that patients with inflammatory abdominal aortic aneurysms (AAAs) can be treated safely and effectively by endovascular aneurysm repair (EVAR), though those with significant hydronephrosis may have worse outcomes.

The retrospective study was conducted between 1999 and 2011 and included 69 patients who underwent either endovascular repair (10 patients) or open surgical repair (59 patients) at the surgeon's discretion.

Dr William M stone, speaking at the annual meeting of the Southern Association for Vascular Surgery, reported that although previous case series and meta-analyses had reported mixed results in cases with EVAR procedures, the current study suggests that EVAR may be considered appropriate management for inflammatory AAAs.

Learn more about the history of EVAR and current devices in this editorial, by Dr R Allison and Dr J Rose.

The full text of the Cardiology News report on the above study can be accessed here.

New MHRA alert for metal-on-metal hip replacements

Tue, 28 Feb 2012 16:10:04 GMT

Today (28/02/2012) the Medicines and Healthcare products Regulatory Agency (MHRA) issued fresh advice to clinicians, following earlier fears for the safety of metal-on-metal (MoM) hip replacements. According to the MHRA, patients with a particular type of metal-on-metal hip replacement should be monitored annually for the life of the hip replacement, and not just for the minimum 5 year post-operative period originally stated in April 2010.

The updated advice features in a new MHRA Medical Device Alert issued to clinicians managing patients with metal-on-metal hip implants, and aims to minimise the risk of such individuals requiring further surgery to correct complications.

Read the full text of the MHRA press release here or link directly to the medical device alert PDF here.

FDA officer advises on live case demonstrations of devices

Fri, 24 Feb 2012 13:18:33 GMT

Dr Andrew Farb, a medical officer at the U.S. Food and Drug Administration (FDA) has advised clinicians on live case demonstrations of devices.

A study in the Journal of the American College of Cardiology: Cardiovascular Interventions suggests that broadcasting heart procedures live to doctors at medical meetings may not present a risk to the patient on the table. Doctors at Rambam Medical Center in Haifa, Israel reviewed 101 patients treated during live transmissions from a single center in 15 invasive-cardiology conferences between 1998 and 2010. The study found that procedural and 30-day clinical outcomes were similar to those found in daily practice and to those that have been reported in the contemporary published data, and concludes that these results suggest that broadcasting live case demonstrations in selected patients from selected centers may be safe.

Such demonstrations must first be approved by the FDA. In an interview with Reuters Health, Dr Andrew Farb, who co-wrote an editorial published with the findings said the main goal of these demonstrations is to increase awareness of a clinical trial, and possibly get more doctors to enroll patients in it. This, he stated, is part of the FDA's "mission" to help get clinical trials done in a timely manner and get effective treatments into practice.

Dr Farb also noted that the demonstrations must clearly state that the procedure involves an "investigational device," and the operators cannot try to commercially promote the device.

The full article from the Journal of the American College of Cardiology can be found here.

Read the Reuters Health interview with Dr Andrew Farb here.

Field safety notice issued for Anaconda and Anaconda ONE-LOK stent graft

Thu, 23 Feb 2012 16:32:20 GMT

The MHRA has issued a field safety notice for the Anaconda and Anaconda ONE-LOK stent graft from Vascutek.

The manufacturer states that it has identified from a small number of field reports (less than 0.05% of the total number of devices distributed) that under exceptional circumstances an additional procedure may be required to remove the bifurcate body delivery system. No product recall is required.

Read the full letter from Vascutek here.

Find out more about the Anaconda AAA stent graft system here.

MHRA issue field safety notice for Biosense Webster CARTO 3 System

Wed, 22 Feb 2012 11:15:13 GMT

The MHRA has issued a field safety notice for the CARTO 3 System which may be susceptible to ablation radio frequency interference through certain interconnected cable configurations. The issue can manifest itself as a jumping or disappearing catheter icon or error messages during ablation.

Biosense Webster have issued a statement identifying the root cause of the issue as a newly introduced Patient Interface Unit (PIU) Backplane card, which is more sensitive to radio frequency interference. Biosense Webster is contacting institutions supplied with one of the affected CART 3 Systems with the new backplane card and will provide alternative equipment.

Read the full letter from Biosense Webster here.

Find out more about the CARTO 3 System here.

Edwards Lifesciences announce promising new transcatheter patient data

Thu, 02 Feb 2012 10:49:21 GMT

Patient data from a recent clinical trial shows reduced mortality rates in high-risk surgical patients with severe aortic stenosis. The patients were treated with transapical transcatheter transapical transcatheter aortic valve replacement (TAVR) during the continued access period of Cohort A of The PARTNER Trial,

The findings on the Edwards SAPIEN transcatheter heart valve were announced this week, and Michael A. Mussallem, Edwards Lifesciences' chairman and CEO said "It is encouraging that, in this much larger group of patients treated with transapical valve replacement, investigators observed a trend toward patients feeling better faster and having improved outcomes. We believe this more recent experience adds strong new support to the transapical procedure as an important option for patients who are at high-risk for surgery."

Read the full press release from Edwards Lifesciences here.

Find out more about the SAPIEN Transcatheter Heart Valve here.

MHRA issues statement on metal-on-metal hip implants

Mon, 30 Jan 2012 14:35:55 GMT

The MHRA have issued a statement on DePuy's metal-on-metal hip implants, while the Telegraph newspaper reports concerns that the devices could be more dangerous than previously thought.

On Monday 30th January 2012, an MHRA spokesman said, "On the evidence currently available the majority of patients implanted with metal-on-metal hip replacements are at low risk of developing any serious problems. We are continuing to closely monitor all evidence. This needs more analysis before any conclusions can be drawn and further advice given.

"We have already taken prompt action to investigate safety concerns and have provided advice on patient management to relevant healthcare professionals. If patients have any questions they should speak to their orthopaedic surgeon."

This statement comes two days after the Telegraph reported on their own investgation into these devices, which found that they were more dangerous than previously thought. The article, published on Saturday 28th January 2012, stated that there were concerns that "the fragments could put the nervous system, heart and lungs at risk of being slowly poisoned". The article also claims that advisers to the MHRA have decided that further advice should be issued due to concerns that the devices could cause “systemic toxicity” in the body.

Read the full statement from the MHRA here.

Read the article in the Telegraph here.

Read our roundup of metal-on-metal hip resurfacings here.

Medtronic completes enrollment of extreme risk patient group in CoreValve trial

Wed, 25 Jan 2012 14:29:40 GMT

Medtronic has announced the completion of the company's patient enrollment in the extreme risk study in its CoreValve U.S. Trial. The company also received FDA approval for an extended investigation (under the FDA’s Continued Access Policy) to continue enrolling extreme risk patients under a Continued Access Study protocol.

David H. Adams, M.D., chair of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center and national co-principal investigator of the CoreValve U.S. clinical trial said, “The CoreValve Trial investigators are very encouraged by our experience using the investigative CoreValve system to treat patients with severe aortic stenosis, and we are eager to fulfill the requirements of the Trial in hopes of offering the valve to more patients in the future.”

Read the full release from Medtronic here.

Find out more about the CoreValve device here.

Which Medical Device launches new anaesthetics device section

Mon, 23 Jan 2012 15:44:50 GMT

Which Medical Device is the authoritative voice for product information, review and opinion in the medical device sector, and we are delighted to add anaesthetics to our existing areas of expertise in cardiology, interventional radiology and orthopaedics. You can browse the new anaesthetics section here.

Dr Ian Nesbitt, Senior Editor for Anaesthetics and Consultant in Anaesthesia & Critical Care said, "increasingly, there are numerous new items of medical equipment available, yet only a limited ability to decide how useful they are in clinical practice. Which Medical Device offers an excellent opportunity for clinicians to read balanced, individualised views of equipment and to contribute their own opinions. This website is an exciting development, and should both simplify and speed up the process of selecting and evaluating equipment for individual and departmental use."

Dr Phil Haslam, Editor-in-Chief and Consultant Interventional Radiologist said, "anaesthetics and critical care is an important section for Which Medical Device, as this specialty uses many different devices ranging from anaesthetic machines and monitoring devices to nerve ablation devices and drainage catheters. There are numerous manufacturers and making the correct device choice is difficult but vital for optimal patient care.”

Have you used any of these anaesthetics devices? Or can you think of a device we haven't featured yet?

If so, we’d love to hear from you. We believe that clinicians want to know what devices are really like from colleagues who use them, and we depend on the reviews and comments of our members to help fellow clinicians make important decisions.

Members can comment on any device on the website, or suggest a product that you'd like us to feature.

Browse all anaesthetics devices here or suggest a new anaesthetics device to add to the site.

DePuy suspends distribution of custom devices following FDA warning

Mon, 23 Jan 2012 10:36:41 GMT

Johnson & Johnson subsidiary Depuy Orthopaedics has decided to stop selling all custom devices following an FDA letter warning. The FDA requires DePuy to file new new PMA or 510(k) applications for several components including:

1. PFC Sigma Knee System with titanium components and Global Advantage Shoulder System with titanium heads;

2. PFC Sigma Knee System components, sizes 2.5, 7, and 8;

3. PFC Sigma Knee System, 30 mm – 40 mm thick inserts;

4. Agility Total Ankle Prosthesis talar components with stems 0.35 inches and longer;

5. Agility Total Ankle Prosthesis talar stems that are round in cross-section and taper downwards;

6. The Agility Total Ankle Prosthesis augments;

7. Global humeral stems 18 mm in diameter;

8. Global Humeral Stems shorter than 120 mm in length;

9. TriFlange Acetabular Cups with outer diameters greater than 66 mm;

10. TriFlange Acetabular Cups indicated for cemented use;

11. Femoral heads that include a 14/16 taper;

12. Femoral heads with offsets greater than +12;

13. Acetabular hip system 14/16 taper adapters; and

14. Adapters to Stryker hip components.

DePuy wrote in a statement that while the company believes it had complied with FDA requirements, it has decided not to provide custom devices at this time.

Read the full FDA warning letter here.

Rise in knee replacements among 30 to 59 year-olds

Fri, 20 Jan 2012 11:54:13 GMT

A study reports a rise in the incidence of knee arthroplasty for primary osteoarthritis among baby-boomers in Finland.

The population-based study published in the journal Arthritis & Rheumatism reports that rates of knee replacement surgery in Finland's 30 to 59-year-olds rose between 1980 and 2006.

Dr Jarkko Leskinen, an orthopedic surgeon at Helsinki University Central Hospital, and colleagues found that Incidences remained higher among women during the whole study period, and most of the increase occurred among patients aged 50 to 59 years. Incidences grew more rapidly in low and intermediate volume hospitals.

The full study can be found here.

Find out more about knee replacement devices here.

Gore receives FDA approval for TAG Thoracic Endoprosthesis

Thu, 19 Jan 2012 14:05:47 GMT

The FDA has approved the GORE TAG Thoracic Endoprosthesis for endovascular repair of the descending thoracic aorta. The device is the first endovascular grafting system approved by the FDA to treat aneurysms of the thoracic aorta.

The full approval letter can be found here.

Find out more about the GORE TAG Thoracic Endoprosthesis here.

Device of the Year 2011 Winners Announced!

Mon, 16 Jan 2012 10:22:49 GMT

We’re delighted to announce the winners of the 2011 Which Medical Device of the Year Awards!

At the end of 2011 we asked our members to tell us the medical devices you simply can’t live without. Our judging panel enjoyed reading your nominations for the most significant, innovative and invaluable devices, and we are delighted to announce the winners in the categories of Cardiology, Interventional Radiology and Orthopaedics.

Many thanks to those of you who nominated devices and congratulations to Olof Brandone who has won six months’ free online subscription to SAGE journals online, courtesy of our partner SAGE.

Have you used one of these winning devices? Share what you think by adding a review. You can also join the conversation on Facebook, Twitter and Linkedin.

Dr Phil Haslam & Mr Craig Gerrand
Editors-in-Chief

And the winners are...

Cardiology

CrossBoss CTO Catheter
BridgePoint Medical

Our Senior Editor for Cardiology Dr Azfar Zaman commends this novel piece of technology with a good success rate in opening chronic occlusions: “it is a quantum leap in the world of CTOs”. Find out more

Interventional Radiology

Amplatzer Vascular Plug II
St Jude Medical

Our judges agreed this device provides easy, fast vessel occlusion replacing the use of multiple coils, and it is an invaluable device in emergency situations. Find out more

Orthopaedics

ALM Pelvic Replacement
Stanmore Implants

Additive layer manufacturing is likely to make a significant impact on the orthopaedic device industry in the next few years, and the convergence of digital technologies in imaging, surgical navigation and implant manufacture offers the promise of new, innovative solutions for patients. Find out more

Runner-up awards

Cardiology (joint runner-up)

SAPIEN Transcatheter Heart Valve
Edwards Lifesciences

Cardiology (joint runner-up)

CoreValve
Medtronic

The judges couldn’t decide between these two devices, which have both stood 'the test of time'. The medium term (five years) performance of both valves is sufficiently robust to hope that TAVI may well become the first preferred option in patients with aortic stenosis. Find out more

Interventional Radiology

Acculis Microwave Tissue Ablation (MTA) System
Microsulis

This device provides rapid tumour ablation with predictable zones and anecdotally less pain than radiofrequency ablation. Find out more

Orthopaedics

GENESIS II Total Knee System
Smith & Nephew

Our Orthopaedics runner-up award goes to the GENESIS II Total Knee System, in recognition of the high-flexion variation which may be of benefit for patients, particularly those who need to kneel. Although there is some debate about this, the Genesis II total knee system is our runner up because of the proven impact it has had on the lives of many patients, with over 5,000 implantations in the England and Wales National Joint Registry in 2011. Find out more

Special Commendations

Cardiology

In Cardiology, special mention is given to the WATCHMAN device from Atritech, which has the potential to improve lives by stopping the need for warfarin in patients with atrial fibrillation, and the ABSORB Bioresorbable Vascular Scaffold manufactured by Abbott Vascular, which we believe is the ‘next generation’ for stents: it promises much but needs to deliver.

Interventional Radiology

In Interventional Radiology, the judging panel also praised the NanoKnife System from AngioDynamics which promises to provide tumour kill whilst maintaining the integrity of blood vessels and other structures close to the tumour, allowing ablation in previously untreatable situations.

Recognition is also given to Gore’s EXCLUDER AAA Endoprosthesis. Our Specialist Editor Dr Andrew Platts praises this timely reworking of a great EVAR device, which uses the C3 delivery system: “still the same graft with ultra low migration and limb occlusion rates, but no longer the terror moment when you pull the string!”

Orthopaedics

Finally, our Orthopaedics judges awarded a special commendation to the KnifeLight manufactured by Stryker, an innovative product which allows surgeons to perform carpal tunnel release without either a traditional open approach or an endoscope by means of an illuminated knife. We liked the simplicity of the idea and the fact it appears to be safe and has published results.

The judges also applauded the Ceruleau Probe from NuOrtho: the only available probe (that we know of!) that allows the debridement of damaged cartilage without injuring healthy tissue and which can be connected to pre-existing electrosurgery machines. Although the long term clinical benefit remains unproven, we liked the principle that normal tissue should not be damaged during surgery, and the preclinical studies that showed this device is different to others on the market.

JACC study suggests increase in CeV events after TAVI

Tue, 10 Jan 2012 12:09:07 GMT

A study in the Journal of the American College of Cardiology found that the incidence of CeV events is highest within 24 hours of TAVI, but this risk may remain elevated for up to two months.

Patients who underwent TAVI were evaluated at baseline, at discharge, at 1 and 6 months, and yearly. Dr John Webb and colleagues at St Paul's Hospital in Vancouver concluded that their findings may have implications for patient selection and antithrombotic strategies.

The full report can be found here.

Find out more about the CoreValve device featured in this study here.

Research shows lower adverse-events for drug-eluting stents than bare metal stents in patients over 85

Wed, 04 Jan 2012 10:35:41 GMT

A report published in the Journal of the American College of Cardiology has observed lower adverse-event rates associated with drug-eluting stents (DES) versus bare metal stents (BMS) in older patients.

This national study compared the effectiveness of DES versus BMS among patients aged 85 or over undergoing percutaneous coronary intervention (PCI).

The full report can be found here.

Compare drug-eluting stents and bare metal stents online.

Study suggests RFA could be first-line treatment for early-stage HCC patients

Tue, 03 Jan 2012 16:40:17 GMT

A study published in The American Journal of Gastroenterology suggests that radiofrequency ablation (RFA) might be a first-line treatment for selected patients with early-stage Hepatocellular Carcinoma.

The report from Japan found that one in four patients with hepatocellular carcinoma treated with percutaneous radiofrequency ablation was still alive ten years later.

Dr Shuichiro Shiina and colleagues at the Graduate School of Medicine of the University of Tokyo concluded that "RFA could be locally curative, resulting in survival for as long as 10 years, and was a safe procedure. RFA might be a first-line treatment for selected patients with early-stage HCC."

The study looked at the Cool-tip ablation system manufactured by Covidien.

The full report can be found here

Find out more about the Cool-tip ablation system here

Study finds catheter-directed thrombolysis reduces the frequency of post-thrombotic syndrome

Thu, 22 Dec 2011 10:29:15 GMT

A study in the Lancet published to coincide with a presentation at the annual meeting of the American Society of Hematology in December 2011 suggests that additional catheter-directed thrombolysis reduces the frequency of post-thrombotic syndrome (PTS) and improves iliofemoral patency.

Tone Enden, M.D. from the University of Oslo in Norway and colleagues investigated whether additional treatment with catheter-directed thrombolysis using alteplase reduced development of PTS.

Read the full study in the Lancet online here

Find out more about thrombectomy devices:

Trerotola thrombolysis device

Rotarex System

Report finds colonic stents provide a bridge to surgery in malignant large-bowel obstruction

Thu, 22 Dec 2011 10:42:03 GMT

A report in the American Journal of Gastroenterology has found that colonic self-expanding metal stents (SEMSs) provide an effective bridge to surgery treatment in patients with acute malignant colonic obstruction.

Dr J. Jimenez-Perez at the Hospital de Navarra in Pamplona, Spain, and colleagues conducted the largest prospective series to date in patients with malignant colorectal obstruction to evaluate the effectiveness and safety of colonic self-expanding metal stents (SEMSs) as an alternative to emergency surgery.

The study looked at the use of the WallFlex colonic stent in 39 centres in thirteen countries.

The full report can be found here

Find out more about the WallFlex colonic stent here

Analysis indicates everolimus-eluting stents can result in improvements for higher-risk patients

Wed, 14 Dec 2011 13:52:33 GMT

Pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) randomized trials has been published in the Journal of the American College of Cardiology.

The study suggests that patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes.

The full report can be found here

Have you had experience of the XIENCE V Everolimus Eluting Coronary Stent? We'd love to know what you think.

Add your review to our device page here

BMJ report finds limited evidence comparing the effectiveness of hip replacement bearings

Tue, 13 Dec 2011 15:16:56 GMT

In a systematic appraisal of the published evidence reported in this week’s BMJ, Sedrakyan et al found that there is limited evidence comparing the effectiveness of different hip replacement bearings. The review was undertaken by the United States FDA in order to create a framework for the post-market evaluation of orthopaedic implants.

The authors examined 3254 abstracts and identified 18 comparative studies, and also reviewed national joint registry reports. They conclude that there is no evidence for improved outcomes in the group with alternative (i.e. metal on metal or ceramic compared with metal on polyethylene) bearings.

The full report can be found here.

Study suggests stent with biodegradable coating reduces risk of cardiac events

Sat, 10 Dec 2011 11:46:35 GMT

A Biosensors study suggests that a drug-eluting stent with biodegradable polymer coating can outperform a SES with durable coating.

The study, published in the Lancet, compared Biosensors' BioMatrix Flex drug-eluting stent with Johnson & Johnson's CYPHER Sirolimus-eluting Coronary Stent. The Biomatrix device reduced the risk of cardiac events associated with very late stent thrombosis, according to the company.

Read the full study in the Lancet online here

Have you had experience of these devices? We'd love to know what you think.

Please add a review to our device pages:

BioMatrix Flex drug-eluting stent

CYPHER Sirolimus-eluting Coronary Stent

Nominations now open for Device of the Year 2011!

Fri, 09 Dec 2011 16:41:03 GMT

It’s that time of year again when Which Medical Device invite you to tell us the device you think should receive a Device of the Year Award. We're asking our members and friends to nominate the crucial medical device you just can't live without!

Nominate your favourite device here. It's simple and quick and you will be entered into a prize draw to win a 6 month online subscription to ALL SAGE Journals Online, courtesy of our partner SAGE.

So if you can you think of a device that deserves recognition - whether it's because it's simple to use, does the job better than any other, shows real innovation or, most importantly, because it transforms the lives of patients, then submit your nomination now!

There will be one winner and one runner up from each device category, Cardiology, Orthopaedics and Interventional Radiology and the deadline for nominations is 31st of December so get yours in fast!

Our expert panel of judges will review the nominations and announce the winners early in the New Year.

Nominate your device here

Find out who won at the 2010 awards here

PleurX peritoneal catheter earns NICE recommendation

Tue, 29 Nov 2011 10:56:09 GMT

CareFusion has received endorsement from the UK's National Institute for Health and Clinical Excellence for its PleurX peritoneal catheter for the management of malignant ascites. Covidien also earned a NICE recommendation for its Pipeline device for the treatment of complex or large intracranial aneurysms.

Find out more about CareFusion's PleurX peritoneal catheter here

Watch a video demonstration of the catheter here

Newcastle's Tissue Engineering Centre aims to develop stem cell treatments for arthritis

Tue, 18 Oct 2011 22:15:22 GMT

Arthritis Research UK has launched a £6 million experimental tissue engineering centre led by Newcastle University. The aim of the project is ultimately to develop biological therapies for osteoarthritis using stem cells. The centre is led by Newcastle University but is a collaboration with The University of Aberdeen, Keel University/The Robert Jones and Agnes Hunt Hospital and the University of York. Professor Andrew McCaskie, Centre Director is hoping to develop treatments which would remove the need for conventional joint replacement by, for example, intervening earlier on in the disease process with arthroscopic techniques.

For the full press release, look here.

MHRA publishes review of medical device incidents in 2010

Sun, 09 Oct 2011 16:37:00 GMT

According to the UK Medicines and Healthcare products Regulatory Agency (MHRA), 2010 saw a total of 10,280 reports of adverse incidents, 13% more than 2009. In 177 of 279 cases where a fatality was reported, there was no established link with the device. Where there was a serious injury, no link with the device was identified in 1,359 of 2,022 cases. 730 manufacturer undertakings were made to improve designs, processes or quality systems.

The range of medical devices supervised by the MHRA is wide and includes assistive technologies, diagnostic devices, pacemakers as well as cardiovascular, imaging and orthopaedic devices. In the latter category, advice about metal-on-metal hip implants featured in 2010, and the MHRA works with the National Joint Registry and the British Orthopaedic Association to ensure a collaborative approach to monitoring devices.

The full report can be found here.

National Joint Registry of England and Wales publishes 8th Annual report

Thu, 15 Sep 2011 20:59:25 GMT

The 8th NJR Annual report was published today at the British Orthopaedic Association Congress in Dublin. The headline figures include:

The largest ever number of data submissions and patient consents
Contains 1.1 million records
Now includes ankle replacements
Patients undergoing hip and knee replacement in NHS hospitals have lower ASA gradings than those in independent hospitals, NHS treatment centres and ISTCs.
Seven year revision rates after hip replacement were 3% for cemented prostheses, 11.8% for resurfacings and 13.6% for stemmed metal on metal bearings.
In knee replacement, seven year revision rates were 3.8% for cemented prostheses, 4.8% for hybrid or uncemented, 16.6% for unicondylar prostheses and 20.4% for patellofemoral implants

For the full report look here.

Medtronic agrees to independent scrutiny of Infuse Bone Graft

Tue, 30 Aug 2011 21:58:51 GMT

Following scrutiny from a US senate committee, Medtronic announced this month that it would give data and $2.5m funding to Yale University to review the safety of their Infuse Bone Graft product. It had been alleged that Medtronic had failed to mention side effects of the product which is a recombinant bone morphogenetic protein 2 (rhBMP-2) used to stimulate bone growth after spinal surgery. The arrangement is intended to allow two fully independent assessements of the data and is unusual in that access to full patient data has been granted rather than the summaries which are normal practice.

For the press release from Medtronic, look here.

For an overview from the BMJ, look here.

Professional societies issue position statement on transcatheter valve therapy

Thu, 30 Jun 2011 20:24:10 GMT

The American College of Cardiology Foundation (AACF) and the Society for Thoracic Surgeons (STS) have published a combined statement on the implementation of transcatheter heart valve replacement. They recommend a combination of good practice measures including team working, data collection in trial settings, nominated centres and good training. This is to be applauded, and reflects concerns about the potentially transformational nature of this kind of intervention, offering therapy for patients who may be considered too unwell for traditional open approaches.

The Edwards Sapien heart valve is one such device. It went on sale in Europe in 2010, and a decision from the FDA in July 2011 is expected to be positive.

Johnson and Johnson Cordis exits the drug eluting stent business

Mon, 20 Jun 2011 22:19:01 GMT

Competition in the drug-eluting stent market has lead to the decision from Johnson and Johnson to stop making the heart devices which it pioneered. This part of the market has been seen as particularly difficult because of law suits around patent infringement. The Cypher stent had been losing market share, and this announcement will also see an end to the development of the Nevo stent, acquired with Conor Medsystems in 2007. The company will continue to focus on devices such as the Exoseal vascular closure device and the Incraft stent graft system for abdominal aortic aneurysm.

Boston Scientific, manufacturers of the Promus coronary stent system saw a rise in its stock price following the announcement.

College of Surgeons recommends improving the dissemination of knowledge about new technologies

Wed, 15 Jun 2011 20:58:00 GMT

The Royal College of Surgeons of England published a report today examining barriers to innovation in surgery and highlighted the fact that surgical studies receive only a small proportion (1.5%) of the total medical research budget. The report makes 15 recommendations including more centralised support for surgical studies, the incorporation of research modules into surgical training, and the establishment of networks of surgical researchers. The one we liked best however, was that the Department of Health and the surgical profession should explore how the best information on new technologies might be disseminated to all relevant surgeons, because that is in keeping with the aims of Which Medical Device. However, there is no doubt that the fundamental differences between surgery and other specialties mean that it is unlikely that surgical studies will ever overtake medical ones (eg new drug trials) in number. The surgical craft requires long training, is highly operator dependent (ie often depends on many individualised decisions and skills which are difficult to allow for in clinical trials) and the time demands of surgical practice make it difficult to combine with a formal academic interest.

Would you still do a metal on metal hip resurfacing? A roundup of hip resurfacing devices

Mon, 06 Jun 2011 22:19:23 GMT

The last few months have been particularly difficult for many involved in hip resurfacing. The flush of enthusiasm for the technology seen five or so years ago has been replaced by a race for the exit for many. Problems with the ASR device in particular have made the headlines and mainstream media, and there is the spectre of further failures to come following the enthusiastic implantation of large bearing metal-on-metal hip replacements on standard stems : the term trunionosis* has been coined and is rapidly being adopted into the orthopaedic vernacular.

It may therefore be an ideal time to review the hip resurfacing devices which have been, and still are available and we have product descriptions for ten of these here.

The list includes devices with established track records, devices which have yet to prove themselves, and devices which have been withdrawn or which may have poorer results than others. In the first category, the Birmingham Hip Resurfacing is perhaps the best established device, with excellent published results. However, it is likely that even enthusiasts are limiting their indications, avoiding younger patients and those needing smaller sizes. Socket placement remains a critical part of the procedure, as experience shows it is particularly important to avoid open sockets and impingement. and patients should be carefully followed up. The ADEPT hip resurfacing is a very similar device, with similar (albeit shorter term) results; the MITCH resurfacing from Stryker is also similar, coming as it does from the same manufacturer, but has few published results to speak of so far, being preentry by ODEP criteria. The Conserve Plus has good results from a single centre and an ODEP 5A rating, but is yet to be widely adopted.

The ReCap Hip Resurfacing has a UK ODEP 3A rating, but appears to have a higher revision rate in the Australian and England and Wales National Joint Registries than the Birmingham Hip Resurfacing. The Cormet 2000 has an ODEP 5B rating, but also has higher revision rates in these registries.

Unknown quantities amongst hip resurfacings include the Minimally Invasive Hip Resurfacing, which is yet to publish results. The ACCIS Hip from implantcast has a unique ceramic surface engineered finish which shows great promise, but for which published results are also awaited.

The ASR Hip Resurfacing has been withdrawn from the market, and the Durom socket withdrawn from sale in the USA. The US version of the latter was a little different from that in the rest of the world, but results elsewhere have not lived up to the promise of the smaller metasul bearing.

It seems likely therefore that the future will see far fewer metal-on-metal hip resurfacings being implanted, and that some of these devices will no longer be used. For some this opens up a gap in the market, which may be filled by devices which are new but also may be unproven (eg short stem hip replacements, ADM X3). It is important that the lessons of hip resurfacing are learned if the potential for similar issues with some of these devices is to be avoided in future.

June 2011.

*Trunionosis The phenomenon whereby wear particles are generated at the trunion or interface between head and stem in a modular hip system. The phenomenon may be exaggerated where there is a large head bearing, and the frictional torque generated at the joint surface is correspondingly large, or where the assembly includes a collar or sleeve between the trunion on the stem and the femoral head.

Editor's note.

Hart points out that this term is misleading because most of the wear occurs on the head side of the taper, rather than on the femoral stem, or trunion. This is important because many meta-on-metal bearing revisions might be possible without changing the stem.

Following on from C4 Dispatches programme, this week's BMJ explores device regulation

Sun, 22 May 2011 18:35:46 GMT

This week’s BMJ is sobering reading for anyone interested in medical devices. In an editorial by Peter Wilmshurst (who is being sued for comments he allegedly made about the STARFlex device) and a series of feature articles, the present regulation and approval processes of medical devices in the United Kingdom and Europe are heavily criticised. The article examines the European device approval process by which privately funded companies determine whether devices meet regulatory standards, and compares it to the US system where the correspondence between regulators and companies is freely available on the Internet (here at Which Medical Device, we have found these letters extremely useful sources of information). Regulators are not required to prove a device has a clinical benefit in Europe, only that it does what it is said to do. The ASR hip features heavily, as in the Dispatches programme earlier in the week. Other devices mentioned include the Birmingham Hip Resurfacing, the ASR XL large metal on metal bearing, and the Sapien heart valve.

The difficulty in obtaining data about devices in Europe extends to recalls. One researcher depressingly found it almost impossible to obtain information about the reason for UK device recalls.

But how to proceed? The relationship between clinicians, regulators and industry is necessarily complex. Clinicians are essential to the development of new devices and have to have a role in their development, but the incentives involved may even unintentionally skew the reporting of results. Clinicians must bear in mind that they are the often the last line of defence between patients and industry and proceed with caution when new devices are involved, whatever the regulators and the companies say. The disincentives for companies to report early problems with devices are similarly powerful – there may be a lot to lose in terms of reputation and financial cost.

Furthermore, it is clear that developing and marketing a new hip replacement, an area in which new devices may only represent an incremental improvement in outcomes for patients, has a different risk/benefit profile to new devices for patients with a serious condition for which there is no other good treatment. Patients need to have access to the potential benefits of new technologies, but not at any cost.

The flurry of media activity around this issue has lead to questions being asked in Parliament and may, in due course, lead to a change in regulation. However, it remains to be seen whether the regulators can improve safety without stifling innovation. Making public all available information about medical devices would be an excellent first step.

Channel 4 Dispatches featuring medical devices

Tue, 17 May 2011 22:24:38 GMT

The UK Channel 4 Dispatches programme on Monday 16 May took on the issue of failing medical devices, with a predictable blend of facts, opinion and patient stories. The programme covered the ASR hip resurfacing, a Medtronic implantable pacemaker/defibrillator and a cochlear implant manufactured by Advanced Bionics, but it was the ASR hip which received the most coverage. The programme makers interviewed Hartlepool surgeons who had implanted the device and were consequently the first to notice early failures. The relationships between surgeons and device companies in the United States in particular came under scrutiny. The main thesis of the programme was that medical devices should be better regulated, need better clinical evidence before coming to market, and that the present arrangements by which devices can be licensed because they are substantially similar to others needs an overhaul – this is a theme that the BMJ had developed late last year.

Which Medical Device (@whichmeddevice) took part in the accompanying Twitter debate (@C4Dispatches, #Dispatches, #HipOp) along with patients, journalists and a fair number of lawyers. Some patients were concerned about upcoming joint replacement operations and some were actively promoting the devices they had in-situ (notably the Birmingham Hip Resurfacing). We were happy to point twitterers to the content on our website, including the product descriptions of a range of hip resurfacings. We were pleased to see the point was made that clinicians and patients need access to the best objective information about devices.

UK users can view the documentary until Monday June 6th via Channel 4's 4oD service.

Synthes to be acquired by Johnson and Johnson in $21bn takeover

Sat, 30 Apr 2011 07:23:45 GMT

The US healthcare corporation Johnson and Johnson has agreed to buy the Swiss orthopaedic implant manufacturer Synthes in a deal worth $21.3 bn (£13bn). The deal is due to complete in the first half of 2012, subject to shareholder and regulatory approval. Some have speculated that this helps Johnson and Johnson manage the product recalls it has had to deal with in the last year (including the ASR hip), and Synthes has had a reputation as having the highest profit margins in the industry. The acquisition may push Johnson and Johnson’s share of the orthopaedic trauma market to around 54%, a market which is expected to grow faster than that for hip and knee replacement, and will also increase their presence in the market for spinal implants.

Synthes has more than 11,000 employees and sales last year of $3.69 billion. Synthes chairman Hansjoerg Wyss has a significant stake in the company and may now become Swizerland’s richest man. Until this deal was announced, Smith and Nephew had also been a target for takeover by Johnson and Johnson.

What's available in Short Stem Hip Replacements

Sat, 30 Apr 2011 17:08:25 GMT

The quest for bone preservation in hip arthroplasty has lead to the development of femoral implants with relatively short stems. The thinking behind these includes not only the preservation of proximal bone stock but possibly also less stress shielding of the proximal femur, ease of revision, reduction of the risk of thigh pain and facilitating minimally invasive surgery, particularly when using an anterior approach. As hip resurfacing declines in popularity, it is likely that there will be a corresponding increase in the number of short stem femoral components in use. We’ve had a look at what’s available.

Short stem hips come in a number of designs and design philosophies, although most are titanium and have hydroxyapatite coatings. At the outset, it might be helpful to mention the Birmingham Mid-Head Resection Prosthesis (BMHR). This device involves resection through the base of the femoral head, has a short conical stem and is designed to be inserted into a reamed cone in the femoral head and neck. It is argued that preserving some of the base of the femoral head results in a shape which is better suited to loading the proximal femur. The stem has a 12/14 taper, and the head and acetabular components are identical to that of the Birmingham Hip Resurfacing, which has avoided some of the problems seen in other metal on metal bearings. Although there are early good results from the originator, long-term results are awaited.

Other short stem devices can be categorized as those with a collar, those without, straight or curved stems, or those which are shortened versions of stems already on the market. The device with the longest track record (98.2% survival at ten years) is the Mayo stem. This is a neck-retaining device which has a proximal wedge-shape for fixation, and the tip touches the lateral cortex, which is at risk of perforation during insertion. The original grit blasted finish has been superseded by a hydroxyapatite coating.

One of the few short stem devices with a collar is the CFP stem from Link, which is an evolution of the Pipino stem. This device has good medium term results (99% survival at 74 months), and the manufacturers report 25,000 implantations since 2000.

Of the remaining collarless devices, the Corin MiniHip and the Collo-MIS stem both have a similar, tapered, curved geometry without a shoulder, but neither have published results. The Aida Short Stem from Implantcast has a more tapered and angled tip to the stem, but again has no published results. Those considering using a new device should review the experience of the CUT Femoral neck prosthesis from Orthodynamics. Although one series demonstrates good results, others have struggled with alignment and offset.

The Metha short hip stem from Braun has a similar geometry to the Aida short stem, but is one of the few of these devices to have an ODEP 3A rating. The Proxima Short Stem Hip from Depuy has a proximal fit and fill geometry, with a larger lateral profile than other stems, but is shorter than some, so care needs to be taken with varus/valgus positioning. It is rated pre-entry by ODEP.

The Silent hip from Depuy is a short, straight stem device, which remains in clinical trials.

The remaining devices, the Fitmore from Zimmer, the SMF from Smith and Nephew and the Taperloc and Balance Microplasty stems from Biomet more closely resemble short versions of established devices, and in the case of the Taperloc and Balance Microplasty stems are overtly so. Once more, there are no or few published results.

To summarise, although there are potential benefits to these shorter stems, particularly for enthusiasts of the anterior approach, the majority of these devices do not have long term results, and there is a need for careful collection of data and clinical trials. In the rush to replace some hip resurfacing devices as an option for younger patients, care should be taken when considering other unproven implants.

A brief history of EVAR and current devices

Fri, 25 Mar 2011 00:00:00 GMT

Dr R Allison, Interventional Fellow, Freeman Hospital, Newcastle upon Tyne, UK.
Dr J Rose, Consultant Interventional Radiologist, Freeman Hospital, Newcastle upon Tyne, UK.

Introduction

The number of endovascular aortic repairs (EVARs) performed worldwide has increased exponentially since its inception at the start of the 1990s. The aortic stent graft itself has evolved from basic tubes to the wide range of modular devices, available in a vast array of sizes, currently in use today. Well established devices with proven efficacy compete with new entries to the market and novel concepts in stent design.

This concise review focuses on the evolution of the endovascular graft and summarises the devices currently in use today.

The evolution of aortic stent-grafts

The first stent grafts used were simple aorto-aortic tube grafts with balloon expandable stents stitched to either end. Initial problems with distal sealing, due to progression of the aneurysmal process in the distal aorta, resulted in a high long term failure rate. This led to the development of devices to fit the iliac vessels and allow a more secure distal seal; initially an aorto-uni-iliac configuration was combined with a surgical femoro-femoral cross-over graft.

1994 saw the introduction of commercially produced bifurcated devices which enabled many more endovascular centres to get involved in the procedure and a shift towards the use of bifurcated devices worldwide. The early single component devices soon gave way to modular component systems, many of which have evolved through a number of iterations to become the devices of choice today.

Over the years the importance of a number of concepts relating to device design has become apparent. Broadly speaking these involve either the delivery system or the stent itself. Delivery systems, once rather cumbersome and rigid have become more flexible, allowing access in extremely tortuous vessels, better proximal alignment and improved accuracy of stent deployment. In addition, re-deployment of the proximal fixation system is now possible. Regarding the proximal stent, supra- and infra-renal fixation systems have evolved, reducing stent-graft migration rates. Evolution of nitinol based systems has produced more conformable devices and will probably result in a reduction in long term stent fractures.

Main bifurcated devices in commercial use

The way device use is regulated varies worldwide. In the USA this is controlled by the Food and Drugs Administration (FDA); within the European Economic Area (EAA) devices must bear the ‘CE’ conformance mark for consumer safety, health and environmental requirements.

Talent – (Medtronic Vascular, USA)
The Talent is a modular (2 piece) stent-graft that has been used worldwide for over 10 years. The introduction system has a hydrophilic coating to reduce friction in tortuous iliac vessels and has stood the test of time with regard to ease of use and accuracy. The graft is a nitinol and polyester fabric graft construction with a non-barbed suprarenal fixation stent. There has been a reduction in popularity in Europe since the Endurant became available. FDA approved & CE marked.

Endurant – (Medtronic Vascular, USA)
This is currently the most widely used device in Europe. Modular 2-piece design, nitinol based with similar polyester graft to the Talent device. Large proximal uncovered nitinol stent; stent configuration in body and limbs designed to increase flexibility and conformability. Small caliber introduction system (18F) facilitates percutaneous EVAR. Unique proximal cap so that the covered body can be deployed prior to releasing the proximal uncovered fixation stent.
CE marked and now also FDA approved since Dec 2010.

AneuRx AAAdvantage – (Medtronic Vascular, USA)
This device has been around since the early days of EVAR, with over 15 years of use and the design now in its 7th generation. Modular two piece device with infra-renal fixation. No longer in common use in Europe but popular in the USA. FDA approved & CE marked.

Zenith Flex - (Cook, Denmark)
Until the release of the Endurant this modular (3 piece) stent-graft was the most widely used stent-graft in Europe and there is a large world-wide experience over 15 years. Large proximal uncovered Gianturco stainless-steel stent; long body design with Z-stent configuration in body and limbs. Flexible 20-24Fr introduction system with a long tapered proximal cap; the covered body can be deployed prior to releasing the proximal fixation stent. Safety wires prevent inadvertent early release of the top cap. Robust device with good long term safety profile. FDA approved & CE marked

Zenith Low Profile (LP) - (Cook, Denmark)
New modular (3 piece) device, launched in 2010 as an addition to the Zenith series. The delivery system is an 18F hydrophilic, braided sheath. Like the Endurant this system facilitates the minimally invasive pure percutaneous approach. The new graft remains Dacron but is held on a nitinol frame with stent shapes that encourage conformability. There is a small top cap above the long suprarenal bare stent which is held in check by a very robust safety wire prior to satisfactory release of the main body. CE marked.

Gore Excluder (WL Gore, USA)
Available world-wide since the early days of EVAR with continuous design improvements and good long-term follow up data. Modular two piece nitinol based device with infrarenal fixation. Longer body, 20Fr profile and larger contralateral limbs available. Recent introduction of a new ‘C3’ delivery system allows repositioning of the proximal sealing stent after initial deployment. This can be a real life saver in the short or difficult proximal aortic necks. FDA approved & CE marked.

Powerlink (Endologix, USA)
Employed in Europe since 1999, the Powerlink device is a unibody bifurcated device. A self-expanding single wire nitinol endoskeleton is covered with ePTFE fabric. The Powerlink is implanted through one surgically exposed femoral artery and a contralateral 9 Fr puncture. FDA approved & CE marked.

Aorfix (Lombard Medical, UK)
Two piece modular infrarenal device, which can be very useful in angulated proximal necks and tortuous iliac anatomy. A proximal (robust and barbed) fixation stent forms a fish mouth when compressed. The unique stent design uses encircling nitinol rings to provide maximum flexibility of the entire stent-graft. Excellent conformability to angulated anatomy. CE marked.

Anaconda (Vascutek Terumo, UK)
The proximal orifice of this 3 piece modular infrarenal device can also form a fish mouth configuration. But in this case proximal fixation is with a double-stent ring which is uniquely leashed to the central introduction cannula. This particular mechanism allows for repositioning of the proximal device in difficult anatomy. The body of the device is largely unstented but nitinol rings in the limbs allow for excellent conformability to angulated anatomy. CE marked.

Ovation (Trivascular, USA)
This is a very new 3 piece device, with the first investigational clinical case implantations in September 2010. The stent graft body (with suprarenal stent) is delivered in a 14F (outer diameter) system, designed to expand the patient population suitable for EVAR by addressing a wider range of diseased anatomies. The proximal seal is provided by hollow rings in the fabric which are expanded by polymer injection after deployment. The stent-graft limbs are inserted separately. CE marked.

Incraft (Cordis, USA)
This stent-graft is undergoing a preliminary trial in Europe. No available images or information regarding design other than the fact that the introduction system is 14F.

Final Thoughts

Over the last 20 years the volume of patients treatable via an endovascular approach has grown consistently, mainly due to advancements in device design. Classically this revolved around new generations of existing devices, with a move towards lower profile delivery systems. Importantly this has enabled EVAR in increasingly tortuous iliac anatomy and also allowed an entirely percutaneous procedure, shown to reduce wound complications compared to surgical cut-downs (1). With increased market place competition, greater number of manufacturers and dedicated research teams, increasingly novel design concepts are being seen; including a yet to be launched polymer fillable EVAR system developed by Nellix Endovascular (USA). No doubt this technology will continue to evolve for the next 20 years and more.

References

1. McDonnell C O: Percutaneous endovascular abdominal aortic aneurysm repair leads to a reduction in wound complications, Irish Journal of Medical Science; 2008 March; Volume 177(1), 49-52

2. Rose J: Stent-grafts for unruptured abdominal aortic aneurysms: current status. Cardiovasc Intervent Radiol; 2006 May-Jun;29(3):332-43

Device and stent specifics taken from currently available manufacturer’s data/IFU.

This article was published as 'Tools of the Trade' in the March/April edition of IR News, published by the Society of Interventional Radiology and was contributed by Dr. Phil Haslam, Interventional Radiology Editor of Which Medical Device.

Can you help to source renal artery RF ablation therapy equipment?

Thu, 24 Mar 2011 00:00:00 GMT

Can you help to source renal artery RF ablation therapy equipment? Senior radiographer and Which Medical Device user warkworth16 has asked for assistance in sourcing the equipment to perform renal sympathetic nerve ablation therapy to treat his wife who suffers from severe refractory hypertension:

"I am currently employed as a Lead Senior Radiographer at a major North East Hospital.

“My wife is suffering from severe refractory hypertension, despite excellent compliance with several anti-hypertensive agents her blood pressure is typically 280/140 mmHg, with a resting tachycardia of around 140 bpm. She has a severely dilated left ventricle, with globally impaired left ventricular systolic function, and has nephritic range proteinuria.

“We were made aware of the renal sympathetic nerve ablation therapy, but she has been turned down for this procedure at Barts. Due to difficulties establishing the renal ablation service, and the option of Harley Street treatment would not be funded by her PCT.

“The hospital I am employed in has a large interventional unit, and despite several of my Consultant colleagues being keen to carry out this procedure, the equipment required cannot be sourced.”

“There has been a significant deterioration in my wife’s condition in the last few months, and as this ablation therapy is the only chance she has of any improvements in her health, I would appreciate any help that can be given in sourcing the equipment necessary to allow interventional colleagues to carry out this procedure.

“Thank you in advance for any assistance that can be offered.”

Update - 17 May 2011

We are please to report that following a campaign by WMD and local Interventional Radiologists we managed to source treatment in London for the patient with refractory hypertension (link to warkorths comment). The patient was treated with Ardian/Medtronics symplicity catheter system for renal RF denervation. Since then her BP has decreased by 40mm Hg systolic and diastolic, tachycardia decreased and her excercise tolerance has increased from a few yards to 1.5 miles. Thank you to everyone who helped with this.

Surgeons cautioned about large diameter metal on metal hips

Tue, 08 Mar 2011 00:00:00 GMT

The British Orthopaedic Association and British Hip Society today published a statement about large diameter metal on metal bearing hip replacements. Several series presented at the British Hip Society Conference demonstrated high revision rates – with the ASR device demonstrating a 49% 6 year revision rate, and others a rate of 12-15% at 5 years. This is in keeping with data already included in the 7^th UK National Joint Registry Report.

Possible reasons for failure included damage at the taper junction between the large head and the stem, wear at the bearing surface and stem corrosion (of uncemented stems). The need to follow up patients for a minimum of five years and possibly the life of the prosthesis was emphasized, and surgeons were cautioned about further implantation of these devices.

Read the statement in full.

BCIS Advanced Cardiovascular Interventions 2011 report

Mon, 14 Feb 2011 00:00:00 GMT

Advanced Cardiovascular Interventions, the annual meeting of UK interventional cardiologists, held in London was a 3 day programme of live cases, lectures and industry sessions. The highlight was the Keynote Lecture given by Kenneth Chien from Massachusettes General Hospital, Boston USA. Professor Chien gave a tour de force of progress in the world of stem cell therapy. Eloquent and enlightening, he gave the gathering a glimpse of the (not too distant) future where injection of prepared and programmed stem cells could effectively repair damaged heart muscle.

Industry sessions focussed on antithrombotic therapy and development of new products for use in coronary intervention.

Dr Carmen Walbert, Medical Director of Medtronic gave an overview of the future role of the interventionalist. She touched on development of the new Integrity range of intracoronary stents with a new coil designed to enhance delivery. She gave an overview of the complete range of Medtronic products in the field of cardiovascular disease. This ranged from stents designed for deployment in the pudendal artery for erectile dysfunction, radiofrequency ablation for resistant hypertension, leadless pacemakers and of course, the Corevalve for the percutaneous treatment of aortic stenosis.

Dr Keith Dawkins, Senior Vice President and Chief Medical Officer of Boston Scientific informed us of the development of the Element family of coronary stents designed to be deliverable, visible and with greater radial strength. We were told that the company had acquired Sadra, a company making aortic valves for percutaneous deployment through an 18F catheter. One novelty of this product is the ease with which it can be placed in position or withdrawn, even after deployment, if position is not ideal.

Dr Sandra Garcia, Marketing Manager, Cordynamic BU Marketing Manager, displayed 2 products for use in the highly thrombogenic milieu of primary PCI. The Hunter thrombectomy catheter is a 6Fr device with the largest inner lumen when compared to competitors. The Amicath is a dual lumen balloon for injecting drugs or contrast beyond an occluded vessel for visualisation distal to the occlusion and/or treating or reducing the “no reflow” phenomenon.

Mr Richard Rapoza, Divisional Vice President and General Manager, Abbott Vascular presented data on the Bioresorbable Scaffold programme. The first generation has undergone thorough evaluation in laboratory testing and the First in Man studies were completed last year in Europe. This is an exciting area and has the potential to transform the field of coronary intervention.

Mr John Shulze of Biosensors Europe, gave the gathering an insight into new technologies for application of drugs onto stent platforms without the need for a polymer coating. Future products could deliver anti restenotic drugs on the abluminal surface and antithrombotic drugs on the luminal surface.
In summary, this was a hugely informative and successful meeting for clinicians and industry.

Dr. Azfar Zaman, Cardiology Editor

DIY implant brings hope to sufferers of Marfan's syndrome

Thu, 10 Feb 2011 00:00:00 GMT

As reported in The Engineer, UK engineer and Marfan’s syndrome sufferer Tal Golesworthy has developed a unique solution to combat one of the effects of the disease.

A serious complication associated with Marfan’s syndrome is aneurysmal dilatation or dissection of the ascending aorta. The traditional treatment for this is open repair with replacement of the aortic valve and ascending aorta. This procedure has significant morbidity and mortality and then requires lifelong anticoagulation.

An alternative is to place an external support around the aorta. Early attempts at producing aortic supports by US surgeon Francis Robicsek failed due to the difficulty of accurately replicating the shape of the patient's aorta.

However, drawing on his background in research and development engineering, Golesworthy initiated the EARS (External Aortic Root Support) project to establish the feasibility of scanning the heart structure and using advances in computer-aided design and rapid prototyping to produce an accurate 3D model of the patient's aorta around which an aortic support could be tailored to fit.

Two years later Golesworthy became the first patient to have the new aortic support implanted and it has now been implanted successfully in more than 20 patients. The device completed its clinical trial in June 2009 and is now commercially avaialble as the ExoVasc distributed by Exstent Ltd.

Ten-year results show effectiveness of resurfacing technology

Thu, 03 Feb 2011 00:00:00 GMT

The January edition of the British Volume of the Journal of Bone and Joint Surgery carries ten year results of a single series of Birmingham Hip Resurfacings from Ronan Treacy, one of the designers and a long term advocate of the device. This series of 144 resurfacings followed up at ten years include his personal “learning curve” and some of the failures relate to technical aspects (such as cup anteversion), the importance of which has only become apparent over the last few years. Patients in the series are predominantly male, for whom the ten year survival of the implant was 98.0%. Problems in the 37 female patients included 8 failures, amongst which were 3 infections and a revision required in one patient who was 70 at the time of resurfacing – not many surgeons would offer resurfacings to patients of this age.

For comparison, the seventh UK National Joint Registry report quoted 5 year revision rates in males under 55 years as 4.4% (3.2% to 6.0%) for cemented hip implants, 4.0% (3.1% to 5.1%) for uncemented implants, 2.6% (1.7% to 3.8%) with hybrid, 5.6% (4.5% to 6.9%) with hip resurfacing (within which group the BHR had the best results – see also results of Conserve Plus – 88.5% survival at ten years (Amstutz et al, 2010)) and 6.4% (4.5% to 8.9%) with large bearing metal on metal hip replacement. The point is made however, that these are 10, rather than 5 year results. In this and other series, smaller components are associated with poorer outcomes.

So what to do when faced with a young patient with hip osteoarthritis? There are alternative approaches (eg custom femoral stem, 97.3% overall 10 year survival, (Muirhead-Allwood 2010), but whether or not you choose a Birmingham Hip Resurfacing, may relate to whether or not you are a believer.

References:

No authors listed. National Joint Registry for England and Wales: 7th Annual Report 2010. Downloaded 29th January 2011.
Amstutz HC, Le Duff MJ, Campbell PA, Gruen TA, Wisk LE.
Clinical and radiographic results of metal-on-metal hip resurfacing with a minimum ten-year follow-up.
J Bone Joint Surg Am. 2010 Nov;92(16):2663-71.
Muirhead-Allwood SK, Sandiford N, Skinner JA, Hua J, Kabir C, Walker PS.
Uncemented custom computer-assisted design and manufacture of hydroxyapatite-coated femoral components: survival at 10 to 17 years.
J Bone Joint Surg Br. 2010 Aug;92(8):1079-84.

Device of the Year 2010 - winners announced!

Tue, 18 Jan 2011 00:00:00 GMT

We ended 2010 by asking our members and friends to vote for our Device of the Year award and identify the crucial medical device that you can’t live without. We're delighted to announce the winners in the categories of Interventional Radiology, Orthopaedics and Cardiology. Many thanks to those of you who nominated devices.

Interventional Radiology

First place goes to Ardian's Symplicity Catheter System. A novel method of renal sympathetic denervation by catheter delivered RF ablation, this device caused a stir in late 2010 with the publication in The Lancet of the Symplicity HTN-2 Trial. We feel this device, and devices like it, have the potential to transform the lives of millions of people with resistant hypertension.

The runner up is the DC bead from Biocompatibles - a way of delivering targeted chemotherapy to colorectal liver metastases with reduced toxcity compared with standard TACE, thus prolonging many patients' lives.

Orthopaedics

The winner in the Orthopaedic category was the Exeter hip from Stryker, recognising the fortieth anniversary of the first implantation and a million hips implanted worldwide. There is no doubt that the device has transformed the lives of patients and its results continue to exceed those of others.

The runner up was the ACCIS hip from Implantcast. In a year in which the shine went off metal on metal bearings, the innovative ACCIS hip technology offers a ceramicised metal-on-metal articulation which avoids the release of metal ions, offering an alternative option to hip resurfacers everywhere.

Cardiology

We have joint winners in the cardiology category - two TAVI (transcatheter aortic valve implantation) devices. The SAPIEN from Edwards Life Sciences and Medtronic's Corevalve represent a quantum leap forwards from open-heart surgery to a percutaneous approach and our Cardiology editor was unable to separate them on performance.

The runner up is the GuideLiner from Vascular Solutions - a rapid exchange, highly flexible guiding catheter allowing excellent support for stent delivery close to the lesion.

Have you used any of the winning devices? Let us know your opinion by submitting a short review.

Will 2011 be an austerity year for healthcare? "Premium" implants may not add value.

Thu, 30 Dec 2010 00:00:00 GMT

In a paper in the January 2011 issue of Clinical Orthopaedics and Related Research, Gloe et al have used a community joint registry in an attempt to identify whether "premium" implants demonstrably add value to hip and knee replacement procedures. "Premium" knee replacements were defined as mobile bearing, high flexion, oxidised-zirconium femoral components or cross linked polyethylene. "Premium" hip replacements included those with ceramic on ceramic, ceramic on polyethylene or metal on metal bearings. Unsurprisingly perhaps, younger patients were more likely to have received a "premium" implant, but there was no difference in the cumulative revision rate, although there were fewer revisions for dislocation in the "premium" hip group, in which large bearings were used more frequently.

The authors make the point that several papers have shown no obvious superiority of high-flexion knees, mobile bearing knees, oxidized zirconium femoral components or moderately cross-linked polyethylene inserts, compared to standard lower cost implants. However, they also point out that more follow up is needed and their study could not assess any functional benefit from "premium" implants.

We think 2011 could see more studies along these lines, and a renewed focus on value for money. What do you think? Please comment on our forum...

The best medical device of 2010?

Tue, 14 Dec 2010 00:00:00 GMT

Good products and services deserve to be acknowledged and rewarded, so Which Medical Device is ending 2010 by asking our members and friends to vote for our Best Device of the Year award and identify the crucial medical device that you can’t live without.

Can you think of a device that stands out because it is simple to use, because it does the job better than any other, because it is innovative or, most importantly, because it transforms the lives of patients?

While we’ve got some definite ideas about contenders, I’m sure that there’s plenty more to recommend as well. So over the next fortnight, we’ll be looking for your suggestions for worthy winners in this area.

There’s no restriction on which medical discipline or type of device so please let us know your nomination by contacting us with one sentence saying why you think your device is a worthy of an award, our expert panel of judges will then pick the best of the rest and publish the results over the Christmas and New Year break.

Ardian's catheter-based treatment for hypertension demonstrates blood pressure reduction

Thu, 18 Nov 2010 00:00:00 GMT

Findings reported at the American Heart Association Scientific Sessions 2010 and published in The Lancet yesterday demonstrated that the landmark Symplicity HTN-2 trial evaluating Ardian’s Symplicity® Catheter System™ met its primary endpoint.

The study showed that, after six months, patients treated with Ardian's device experienced an average drop in blood pressure of 32/12 mmHg compared to an increase in blood pressure of 1/0 mmHg in the control group of patients treated with medical therapy alone (p<0.0001).

Research has shown that each incremental 20/10 mmHg increase of blood pressure above normal levels is associated with a doubling of cardiovascular mortality over a 10 year periodⁱ and that reducing systolic blood pressure by as little as 5 mmHg can reduce the risk of stroke by almost 30 percent.ⁱⁱ

“The impressive results of this study show that Ardian’s Symplicity System has the potential to become a truly revolutionary treatment,” said Murray Esler, M.D., Ph.D., principal investigator of the trial and associate director of the Baker IDI Heart and Diabetes Institute of Melbourne, Australia. “Combined with findings from the earlier Symplicity HTN-1 study, which demonstrated the safety and durability of the therapy out to two years, these results fuel our enthusiasm for the potential of this treatment to significantly impact the standard of care for the large number of patients suffering from this disease.”

The Symplicity HTN-2 trial was an international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension. One hundred-six patients were enrolled from 24 investigational sites. At baseline the randomized treatment and control patients had similar high blood pressures: 178/97 mmHg and 178/98 mmHg, respectively, despite both receiving an average daily regimen of five antihypertensive medications. After six months, the average blood pressure of the renal denervation group was reduced to 146/85 mmHg, compared to an average blood pressure of 179/98 mmHg for the control group.

The study also found that the therapy was safe, with no serious device or procedure-related events, no cardiovascular complications and no kidney-related complications.

i Lewington S., et al. Lancet. 2002;360:1903-1913.
ii Mohr, J.P., Churchill Livingstone, 2004.
iii Mathers, C., et al. World Health Organization; 2009.

Write a review and win an iPad!

Thu, 18 Nov 2010 00:00:00 GMT

We want to reward our best contributors and are therefore offering an Apple iPad for the best review and iPod touch for the best user comment before Monday 13 December 2010.

Which Medical Device is an independent review website for medical devices. We aim to provide users with all the information they need to make decisions about which devices to use. This information includes independent user reviews, editorial comment, discussion forums and information provided by manufacturers. We believe that users want to know what devices are really like from colleagues with experience: the more discussion there is, the more likely it will be that clinicians will be able to make better decisions about devices for their patients, and understand how to make best use of them.

The site very much depends on your independent reviews and comments.

Reviews are easy to write and are based on the design and features of the equipment, what it’s like to use (i.e. does it do what the manufacturer says it does), comparisons with any similar equipment and a score out of 5. Members of the site can also post their own comments and images of equipment in use. As a device reviewer you must be an experienced user of the product. You will also need to declare ‘no conflict’.

Each review we publish also earns impact factor points. These points will increase your ranking in the community. If revenue permits we hope to reward those with the most points at the end of each year.

Remember your review will be read by an international audience of over 2,000 members and the site receives over 4,000 visitors a month! Please get in touch at info@whichmedicaldevice.com if you think you can contribute.

BSIR discuss off-label device use

Mon, 15 Nov 2010 00:00:00 GMT

This years BSIR (Liverpool UK) featured an interesting plenary session on ‘off label use of devices-is it legal?’

The speakers included:

Dr Susanne Ludgate giving the MHRA perspective
Mr Peter Merchant giving the legal perspective
Professor Duncan Ettles giving the radiologists perspective

Innovation often comes from the use of a device in an unusual scenario, perhaps a use for which the device was never intended. We’ve probably all done this at times, eg use of a Foley bladder catheter for a replacement gastrostomy tube, thrombin injection for pseudoaneurysms. The session heavily revolved around where we stand legally in using devices ‘off label’.

My understanding is that if a device is used ‘off-label’ and the patient comes to harm then the practitioner may not be prosecuted provided that it is accepted practice to use the device in that way by other clinicians. If it is deemed necessary to use a device ‘off label’ then it is advised that the following are undertaken:

1. A documented risk assessment is carried out.
2. Consider the ethical and legal implications
3. implement suitable precautions to minimise risk
4. Review the risk assessment at suitable periods
5. Inform the patient and gain their consent
6. Record the same in the patients notes
7. Ensure the patient is made aware of the risks
8. Any problems with the device/IFU should be reported to the MHRA (in UK)
9. Discuss the proposed use with colleagues to seek advice and inform the risk management team in the trust.
10. Record the use in the patients notes and the reasons for use.

Clearly all these actions cannot be undertaken in an emergency situation and that could pose problems. How many of use have taken these actions prior to the use of thrombin for treating pseudoaneurysms ? This technique was first published in 1986 and then was revived in the late 90s for femoral pseudoaneurysms. The alternatives to its use are surgery (potential risk) or compression, which is both time consuming and painful. The interesting thing here is that thrombin is not only unlicensed for this use, but its intravascular use is specifically contraindicated in the IFU. You could argue that a pseudoaneurysm is not truly intravascular. I and my colleagues were among the first to undertake this treatment and clearly at this stage in its evolution it was not established practice and if we had a complication we could well have been liable. However we would now have more colleagues to support us.

I am keen to get some discussion going on ‘off-label’ device use and have opened a topic in the forum. Please contribute your opinions.

Further information on this topic can be found at:

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON065771

http://druganddevicelaw.blogspot.com/2009/04/off-label-use-and-medical-malpractice.html

http://www.mesotherapyworldwide.com/images/pdf/Amer_Journal_Mesogun.pdf

BMJ feature recommends tighter controls on devices, but is this really the way to go?

Fri, 05 Nov 2010 00:00:00 GMT

In this week’s British Medical Journal (6^th November 2010), an editorial and a feature article raise concerns about regulatory approvals for medical devices, particularly in relation to the FDA’s treatment of an implantable vagus nerve stimulator.

There are concerns that the regulatory traditions of the device world lag behind those of the pharmaceutical, and in particular that the present system allowing approval of devices on the basis that they are “substantially similar” to existing devices is not rigorous enough. Observers of the FDA will have noticed that approval to market a device for meniscal replacement in the knee (the Menaflex Collagen Scaffold) has recently been withdrawn after the realization that the device was in fact not as similar to preexisting (predicate) devices as had been thought – in particular it was intended to stimulate the growth of new tissue rather than replacing it

The leader by Jerry Avorn (Professor of Medicine at Harvard) in the BMJ complains that devices are not routinely held on a register, making post marketing surveillance difficult and points out interestingly that stents used for treating peripheral arterial disease were in fact only approved for the treatment of biliary duct stenosis.

The feature article by Jeanne Lenzer and Sharon Brownlee discusses the problems associated with the use of an implantable vagus nerve stimulator (VNS) manufactured by Cyberonics and used for the treatment of epilepsy not responding to drug treatment. Deaths have been reported amongst patients with the device, some of whom have had asystolic episodes which improved after the device was deactivated. The proposed solution includes a requirement for manufacturers to register adverse events and independent monitoring of outcomes.

Whilst the need to protect patients is important, it is to be hoped that the regulators avoid a response that makes it more difficult for new devices to get to market. The system for regulating drugs is not without its problems – clinical trials are expensive because of the underlying assumption that drugs should be absolutely safe and the trials process is prohibitively expensive. Many new pharmaceutical agents that could help patients never make it to market because of these economic and regulatory considerations. Getting the balance of risks right is tricky. Calling for tighter regulation is easy – doing what is really best for patients is not.

Top 10 Medical Innovations of 2011 - if you have deep pockets

Thu, 04 Nov 2010 00:00:00 GMT

It’s the time of year for top 10 lists. Here’s an interesting one from the staff of the US based Cleveland Clinic who have gazed into their crystal balls and nominated their pick of the top 10 medical innovations for 2011. The list includes early detection technologies for Alzheimer’s disease, a targeted T-cell antibody for melanoma and a cancer vaccine for metastatic prostate cancer.

The devices making the list include an implantable device for remote monitoring of cardiac functioning, the Trans-Oral Gastroplasty device (TOGA) for weight loss, and capsule endoscopy for the diagnosis of paediatric GI disorders.

Like any top 10 list, this list is subjective and reflects the perspective of the judges. It also has a high-tech North American feel to it. Elsewhere in the health care industry the idea of implementing low cost technologies from the developing world in the cash-strapped systems of the developed world is gaining traction. This “reverse innovation” has lead to the dissemination of ideas such as oral rehydration solutions for children with diarrhoea, the Aravind Eye Care System for low cost cataract surgery and a low cost ECG machine from GE, developed for emerging nations and now adopted globally. In these straitened times, 2011 could in fact be the year of “reverse innovation”. What do you think?

Annual Report of UK National Joint Registry supports back to basics approach

Mon, 18 Oct 2010 00:00:00 GMT

For those about to launch into using a new design of hip or knee replacement, the highlights of the seventh UK NJR report included:

Almost 1 million registered procedures.
65,000 primary hip replacements and 78,000 knee replacements registered in 2009
The number of cemented hip replacements has fallen significantly from 53% in 2004 to 36% in 2009.
The Exeter V40 stem and Contemporary socket are market leaders amongst cemented implants: the Corail stem and Pinnacle socket are market leaders in uncemented hip implants.
Revision rates were lowest for cemented hip replacements and highest for Metal-on-Metal hip resurfacings.
The number of hip resurfacings is falling (5,707 in 2008 to 4,099 in 2009), with the Birmingham Hip Resurfacing being the market leader, but the number of larger head bearings is increasing.
The PFC Sigma is the market leader amongst total condylar knee replacements.

The full report available at www.njrcentre.org.uk.

Which Interventional Device has become Which Medical Device.

Tue, 28 Sep 2010 00:00:00 GMT

We hope you like the new site and find it as easy, or even easier to use than the old site. We have now added cardiology and orthopaedics to the site and plan to increase the numbers of specialties covered in the near future. There are many devices and techniques that can be shared between specialties and we hope that we can all learn from this cross fertilisation of ideas.

As a registered member you can search device reviews, upload your own reviews, comments and images, view videos of devices in use and discuss complex cases with clinicians from around the world. Membership is open to clinicians and allied health care professionals.

We have an international panel of independent experts who write high quality reviews of the devices they use, but we are always looking for new contributors. Write a device review and earn points for your work. Your review will be available to over 4,000 visitors a month from around the world.

We are giving away an Apple iPad to the member who contributes the best original device review and an Apple iPod Nano to the most helpful comment on device use up to the end of November 2010 !

Outbreak of faith coincides with Pope's visit to Glasgow

Wed, 22 Sep 2010 00:00:00 GMT

The Smith & Nephew poster outside the Combined Orthopaedic Societies meeting in Glasgow raised a few smiles as the meeting coincided with the Papal visit to Scotland. The implication was that however the debate about metal on metal bearings went, and in reference to the faithful receiving the blessing of the Pontiff, you either believe or you don't.

The Smith & Newphew poster at COMOC 2010

Inside the meeting, it was interesting that despite podium presentations on the value of good evidence for orthopaedic practice, many of the exhibitors were showing devices without published results which might be seen as jostling for position in the gap in the market left by the flight from metal-on-metal bearings. These included large ceramic bearings and dual mobility hips, examples of the latter being made by Stryker, Biomet and Medacta. Another trend was the number of manufacturers showing knee replacements with customised jigs, such as the Biomet Signature and the Medacta Global knee system, claiming advantages including a smaller number of trays, and the benefits of navigation without a large machine in theatre.

DePuy ASR Hip System withdrawn from sale

Thu, 16 Sep 2010 00:00:00 GMT

A UK MDA alert issued on 7th September states that the DePuy ASR hip system has been withdrawn from the market. This follows reports of relatively poor results for the resurfacing system and should come as no surprise following earlier MDA alerts.

ASR sockets and resurfacing heads should be taken off the shelf and returned to the manufacturer. The MDA recommends that patients with implanted devices should be contacted and followed up.

Hip resurfacings and metal-on-metal bearings have been the subject of some controversy recently and it seems inevitable that the market share will decline. However, the decline in metal on metal bearing use has opened the way to other new unproven devices, with demand driven by direct to patient marketing. These include DePuy’s Delta Motion hip and Stryker’s “mobile bearing” ADM hip, both of which are said to provide advantages for younger patients. It remains to be seen whether these new devices catch on, or whether we see a return to more standard tried and tested devices.

Study shows treatment with SES in CTOs results in less restenosis compared with BMS

Mon, 19 Jul 2010 00:00:00 GMT

Latest study results have shown that in chronic total occlusions (CTOs), treatment with sirolimus-eluting stents (SES) leads to less restenosis at eight months compared with bare-metal stents (BMS). Patients who receive SES also require less repeat revascularisation at two-year follow-up, according to randomised clinical trial data published online June 20, 2010, ahead of print in the European Heart Journal.

For the GISSOC II-GISE trial, researchers led by Dr Paolo Rubartelli, Ospedale Villa Scassi (Genoa, Italy), enrolled 152 patients at 13 Italian centres between May 2005 and September 2007. Patients, who all had de novo CTOs present for at least 30 days in a native coronary artery, were randomised to receive SES (n=74; Cypher, Cordis/Johnson & Johnson, Miami Lakes, FL) or BMS (n=78; Bx Sonic, Cordis). Angiographic follow-up was performed at eight months, and clinical follow-up was conducted through 24 months.

Eight-month restenosis favours SES

Angiographic follow-up was obtained at a mean of 8.4 months in 84% of the cohort. The primary endpoint of in-segment minimal lumen diameter was larger with SES treatment, which also produced less in-segment late lumen loss and binary restenosis. Total reocclusion occurred in 16.9% of BMS patients but in none of the SES patients (P = 0.001).

At 24-month follow-up, SES and BMS patients had similar rates of most clinical outcomes. The rate of MACE (defined as death, MI, emergent CABG, TLR, or TVR) was lower with SES treatment, driven mainly by a reduced need for repeat revascularisation. Angina and silent ischaemia were also less common in SES patients.

Subclavian access feasible and safe with transcatheter device

Mon, 19 Jul 2010 00:00:00 GMT

In patients undergoing transcatheter aortic valve implantation (TAVI), subclavian access may be feasible for those with anatomical or disease characteristics that discourage the standard femoral approach. The new technique appears to be associated with high rates of procedural success and few in-hospital complications, reports a study published online July 6, 2010, ahead of print in Circulation: Cardiovascular Interventions.

Study design

Researchers led by Dr Anna Sonia Petronio, University of Pisa (Pisa, Italy), and colleagues looked at 514 consecutive patients who underwent TAVI using the CoreValve device (Medtronic) from June 2007 to July 2009 at 13 Italian hospitals. Among this cohort, 54 were treated with the subclavian approach at ten of the participating centres (mean of 5.4 patients treated per hospital). The majority of patients (n = 460) underwent femoral access.

According to the researchers, surgical risk was high in the overall study population, as evidenced by the mean logistic EuroSCORE of 20.1. Patients in the subclavian group had higher mean EuroSCORE and higher rates of comorbidities including PAD, CAD, carotid artery stenosis, prior MI, and prior PCI than those in the femoral group. However, subclavian patients were less likely to be New York Heart Association (NYHA) Class III/IV.

Clinical follow-up was obtained for a median of 6.9 months. At 30 days and six months, adverse event rates did not differ between the groups. Mortality was similar with subclavian and femoral access through six months. MACCE rates were primarily driven by mortality; stroke was almost always fatal while MI and reintervention were rare. Major bleeding and valve-related events occurred at equal rates regardless of access route.

Overall, improvement in NYHA functional class was “remarkable”, the researchers comment. At 30 days, 82% of the femoral group and 77.8% of the subclavian group showed at least a 1-class increase. This improvement was sustained at six months in 80.9% and 78.1% of patients, respectively.

Based on their findings, “vascular access through the subclavian artery can be considered a valid strategy in patients with contraindications to the femoral approach, allowing for enlargement of the eligibility for TAVI with the CoreValve,” Petronio and colleagues concluded.

New research reveals Genous Bio-engineered R stent is safe and effective in combination with drug-eluting balloon

Mon, 19 Jul 2010 00:00:00 GMT

Six-month clinical follow-up data presented at the World Congress of Cardiology Scientific Sessions 2010 in June, showed the safety and efficacy of the combination of pre-dilatation with a paclitaxel drug-eluting balloon (Sequent Please, B.Braun) followed by implantation of the Genous Bio-engineered R stent (OrbusNeich) for the percutaneous treatment of coronary artery stenosis.

Study design

In the investigator-initiated, single centre, all-comers POTENT (Paclitaxel-eluting ballOon and bio-engineered progeniTor cEll-attracting stainless steel steNT in percutaneous treatment of coronary artery stenosis) registry, 32% of patients were diabetic, 86% were male, 58% had a previous myocardial infarction and the mean age of the study population was 56 years. Of the lesions treated, 46% were type B2/C lesions. The patients received a pre-loading of dual antiplatelet therapy (DAPT) at least six hours prior to the percutaneous coronary intervention, and the DAPT was continued for three months. There were no in-hospital or 30 day major adverse cardiac events (MACE) reported. There was one case of late stent thrombosis.

In the six-month clinical follow-up of the 50 patients in the study, the MACE rate was 6%, and the clinical driven target lesion revascularisation (TLR) rate was 4%. In an optional nine-month angiographic follow-up of 35 patients, no patients exhibited binary restenosis.

“We are very encouraged by the low MACE and binary restenosis rates, which are comparable to other stenting strategies and demonstrate the potential for combining drug-eluting and pro-healing technologies,” said Dr Tiong-Kiam Ong, Sarawak General Hospital, Malaysia, and principal investigator of the study. “This therapeutic strategy could be a potent remedy for the dual problem of in-stent restenosis and stent thrombosis.”

Longer length GORE VIABAHN Endoprosthesis receives CE mark approval

Mon, 19 Jul 2010 00:00:00 GMT

The GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface has recently received CE mark approval. The new 25cm device is the longest length stent-graft available, designed to cover more of the lesion in the superficial femoral artery (SFA) potentially reducing the need for multiple devices.

The device features a precision laser trimming technology used to remove excess material, resulting in a contoured proximal edge that may improve flow dynamics at the proximal end. Removal of excess material at the proximal edge improves device apposition to the vessel wall when oversizing prevents device expansion to its nominal diameter. The device also incorporates the PROPATEN Bioactive Surface which utilises end-point immobilisation of derivatised heparin to the endoprosthesis luminal surface. This proprietary surface technology preserves the heparin bioactive sites such that they remain free to interact with the blood at the device surface without being consumed. The original GORE HEMOBAHN Endoprosthesis was introduced to Europe in 1996; the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface was first approved for use in the EU in December 2008.

“In 1996, the [GORE] HEMOBAHN-VIABAHN device was the first SFA stent-graft that had good patency rates and it came already in 15cm length,” said Dr Jacques Bleyn, Antwerp Blood-Vessel Center, Antwerp, Belgium. “Because long SFA occlusions can be treated endovascularly with the GORE VIABAHN device, Gore took this best SFA device and made it better: heparin bonded and a new length of 25cm.”

The device is available with a low-profile delivery system that gives interventionalists a more streamlined approach to re-line the peripheral arteries. It is constructed with a durable, reinforced, biocompatible, ePTFE liner attached to an external nitinol stent structure. The excellent flexibility of the endoprosthesis enables it to better traverse tortuous areas of the SFA and conform more closely to the complex anatomy of the artery.

Longer balloons provide physicians more options for treating peripheral artery disease

Mon, 19 Jul 2010 00:00:00 GMT

Boston Scientific has announced that 22 new balloon sizes have been added to the PolarCath Peripheral Dilatation System, including balloon lengths of 120 and 150mm.

The new PolarCath balloons are available in both 0.014-inch and 0.035-inch guidewire-compatible platforms. The PolarCath System also offers balloon lengths of 20, 40, 60, 80 and 100mm.

"The expanded portfolio of PolarCath balloons will enable interventionalists to address longer lesions in the femoral and subfemoral arteries, often more efficiently than using several shorter balloons,” said Dr Tony S Das, Director of Peripheral Vascular Interventions at the Presbyterian Heart Institute, Dallas, US. “The PolarCath System also offers the potential benefits of CryoPlasty Therapy for these complex lesions.”

Pre-market approval submission for the Zilver PTX Drug-Eluting Stent Platform

Mon, 19 Jul 2010 00:00:00 GMT

Cook Medical has submitted its Pre-Market Approval (PMA) application to the FDA for the company's polymer-free Zilver PTX Drug-Eluting Peripheral Stent. Intended for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA), is a self-expanding, highly durable nitinol stent that uses a proprietary, polymer-free technology to deliver a locally therapeutic dose of paclitaxel, an antiproliferative drug, to the target lesion.

Cook's PMA submission includes data from the randomised portion of the ongoing Zilver PTX clinical trial, the largest study of its kind for the endovascular treatment of PAD in the superficial femoral artery (SFA).

Study update

Encompassing a global single arm registry and a randomised study involving 1,276 total patients including diabetics, symptomatic patients and those with complex lesions, the 479 patients enrolled in the randomised study and the 787 in the single arm study are experiencing clinical improvement, excellent stent durability (i.e., fracture resistance), high rates of event-free survival and freedom from target lesion revascularisation. Patency data from the single-arm study was reported at 86.2% at 12 months at EuroPCR in June.

CE mark approval for the RePort Guide Catheter System

Mon, 19 Jul 2010 00:00:00 GMT

Reverse Medical Corporation recently announced that it has received CE mark for its RePort Guide Catheter System, intended to provide intracranial access during interventional neurovascular procedures.

The RePort Guide Catheter System provides the neurovascular specialist with a new tool that can navigate deeply into the cerebral vascular anatomy, enabling them to treat more patients than with currently available technologies.

Reverse Medical scientific and clinical advisor Dr Satoshi Tateshima, UCLA Interventional Neuroradiology, Ronald Reagan UCLA Medical Center, Los Angeles, CA, stated, “The neurovascular anatomy often presents challenges related to fundamental access, and deep brain therapeutic microcatheter navigation support. The RePort Guide Catheter System design represents a game changing advancement over other guide catheters available today. The system is designed to be used across a broad range of neuro interventional procedures. It has also been designed to enable placement beyond the skull base more easily and safely than other currently available devices. I look forward to its US commercial availability in the future.”

The company plans to commence commercialisation during 2010.

Pathway Medical Technologies receives FDA clearance for JETSTREAM atherectomy system

Mon, 19 Jul 2010 00:00:00 GMT

The FDA has granted the Pathway Medical Technologies 510(k) clearance to market JETSTREAM G3 SF (Small Fixed), the newest version of its peripheral revascularisation catheter for the treatment of peripheral vascular disease (PVD). The smaller size, fixed cutter and longer catheter length make JETSTREAM G3 SF an ideal option for treating blockages below-the-knee (BTK). JETSTREAM G3 SF allows physicians to treat a broader range of PVD patients, including the greater number of patients with critical limb ischaemia (CLI) and diabetes in the BTK population.

“The JETSTREAM G3 SF gives me a new tool in my arsenal to treat a wide range of PVD patients, including those with blockages in smaller arteries below the knee,” said Dr Malcolm T Foster III, research director at East Tennessee Heart Consultants and physician at Mercy Medical Center West, Knoxville, US. “In particular, patients with diabetes have often faced the threat of amputation due to poor circulation in the extremities. With JETSTREAM, some of these patients now have a viable option for treating CLI and saving their limb.”

According to the company, JETSTREAM G3 SF is the only below-the-knee device on the market that offers active aspiration. It is optimised for below-the-knee blockages and features a smaller, fixed cutter designed for enhanced performance in tortuousity and better navigation of the device through arteries of the lower leg.

CoreValve System shows long-term efficacy and durability in pivotal trial

Fri, 04 Jun 2010 00:00:00 GMT

New clinical data presented at the recent EuroPCR held in Paris (May) demonstrated positive long-term performance and durability for the CoreValve transcatheter aortic valve replacement system from Medtronic.

The system, designed to replace a diseased aortic valve without open-heart surgery or surgical removal of the native valve, has now been implanted in more than 10,000 patients worldwide in 32 countries outside the US. Typically delivered through the femoral artery, CoreValve is used in 75% of transarterial transcatheter valve replacement procedures.

“These pivotal trial results provide important evidence and confidence to physicians that CoreValve is an effective long-term treatment alternative for many patients with severe aortic stenosis who are considered at high surgical risk or inoperable,” said Dr Ulrich Gerckens, HELIOS Heart Center Siegburg, Siegburg, Germany. “Without valve treatment this patient population faces a 50% chance of survival from cardiovascular events at two years. In contrast, patients who received CoreValve have a greater chance of survival and overall better heart function.”

The study evaluated 126 patients at nine centres in Europe and Canada who were implanted with the currently marketed 18F CoreValve system. Investigators reported the following study results:

Two-year effectiveness data: About three quarters (73%) of patients saw their heart failure symptoms improve substantially (one or more NYHA class improvement). Valve opening area increased 2.5 times from baseline on average and remained stable at two years. Resistance to forward flow through the valve (peak and mean valve gradient) was decreased by 75 to 80%.
Two-year survival data: Two-year cardiac survival was 74%.
Two-year valve performance: Over two years, no valve migrations or valve deterioration occurred.

The CoreValve system received CE mark in March 2007. It is not yet available in the US for clinical trial or commercial sale or use.

Sterling SL Balloon Catheter is launched in US and Europe

Fri, 04 Jun 2010 00:00:00 GMT

Boston Scientific announced the US and European launches of the Sterling SL PTA balloon dilatation catheter, a high-performance balloon dilatation catheter designed for use in peripheral angioplasty procedures below-the-knee. The company plans to launch the product immediately in both markets.

The Sterling catheter provides a low tip profile, deliverability and rapid deflation time. “The introduction of the Sterling SL Balloon Catheter will provide the length options I need to address below-the-knee procedures for patients with peripheral artery disease,” said Dr Kenneth Kollmeyer, DFW Vascular Group and Chief of Vascular Surgery, Methodist Dallas Medical Center, US.

iVAS Inflatable Vertebral Augmentation System is launched

Fri, 04 Jun 2010 00:00:00 GMT

Stryker's Interventional Spine business unit announced the release of its iVAS inflatable vertebral augmentation system, a minimally invasive device cleared for use in treating vertebral compression fractures (VCFs).

The device is part of a range of mixer and delivery systems, bone cements and needles for both vertebral augmentation (balloon kyphoplasty) and vertebroplasty.

iVAS is designed with five key features that help promote enhanced procedure efficiency and outcomes:

The stiff distal balloon catheter provides rigidity for smooth insertion.
A flexible proximal catheter allows for easy maneuverability.
The radiopaque markers on the balloon catheter helps facilitate accurate visualisation and placement of the balloon.
The hand drill cuts cleanly through cancellous bone to create a channel for balloon placement.
Graduation markings on the access cannula assist in measuring needle depth.

First US implant of RENEW, interspinous allograft technology for treatment of lumbar spinal stenosis

Fri, 04 Jun 2010 00:00:00 GMT

The first commercial implant recently took place in the US of the RENEW Interspinous Allograft Technology (Interventional Spine) for the treatment of lumbar spinal stenosis (LSS).

The RENEW Implant is an interspinous process device made from allograft for the treatment of lumbar spinal stenosis. Designed for ease of implant and to provide a more ‘natural’ interference within the spinous process, the company believes that this innovative device will improve outcomes and provide cost efficiencies to hospitals and surgeons.

The implant is available in six different sizes to accommodate the patient’s anatomy.
The first implant was performed at the Inova Fairfax Hospital in Fairfax, Virginia, by Dr Ronald C Childs. Upon completing the procedure, Childs commented: “I am very pleased with this product. The use of the RENEW implant provides, in my view, a welcomed alternative to the other various interspinous process devices made from synthetic materials presently in the market.”

VIBE RX: New vascular imaging balloon catheter

Thu, 03 Jun 2010 00:00:00 GMT

Volcano Corporation has received CE mark approval for the VIBE RX Vascular Imaging Balloon Catheter. The company also announced that it has completed its first clinical cases with the VIBE RX in New Zealand. A single VIBE RX Catheter can quickly access, prepare, and assess challenging lesions. IVUS guidance provides precise, targeted balloon dilatation with immediate confirmation of interventional results.

According to Dr John Ormiston, Medical Director at Mercy Angiography in Auckland, New Zealand, “Volcano has successfully combined two important interventional tools – IVUS and balloon dilatation into one powerful device. “Physicians will have an attractive alternative to using separate IVUS and balloon dilatation catheters in a procedure. The use of imaging for more precise lesion assessment and stent placement has certainly benefited my patients. Integrating imaging directly onto the therapy device removes another barrier to IVUS use.”

New indication for complete self-expanding stent receives FDA approval

Thu, 03 Jun 2010 00:00:00 GMT

Medtronic announced in April 2010 that it has received approval from the FDA for the Complete SE Vascular Stent System to be used for the treatment of peripheral arterial disease (PAD) in the iliac arteries.

The Complete SE Vascular Stent System features several novel advances, including an innovative dual-deployment delivery system with a unique triaxial design. The new delivery system is made up of an inner shaft, a retractable sheath and a stabilising sheath that reduces friction and allows the retractable sheath to move back freely. This decreases the amount of force required to deploy the stent, thereby making deployment easy and precise.

Closure device uses single suture, steel ring

Thu, 03 Jun 2010 00:00:00 GMT

The Quick-Close Vascular Suturing System from Interventional Therapies LLC received FDA clearance in April 2010. It consists of the Quick-Close Suture Applier and the Quick-Ti Cinch Applier. The suture applier has a pistol grip shape and contains a single strand of an artificial suture (polybutester Novafil) fitted with stainless steel rings.

The suture applier is used to gain access to the puncture site. Using manual control, and relying on the sense of touch, the device is used to place one end of the suture through one edge of the arterial wound. The suture applier is then repositioned and the other end of the suture is inserted through the opposite edge of the wound site. As the suture applier is withdrawn from the wound, a 24-inch length of suture is forced out of its housing. The suture applier places a single stitch of a non-absorbable, single thread suture to the wound site. The cinch applier gathers the two ends of the suture and then it places a stainless steel ring that acts in place of a knot to secure the suture in a closed position to stop the bleeding.

It is designed for use in vascular punctures with diameters of 4mm or larger.

First implants of TX2 thoracic endograft completed

Thu, 03 Jun 2010 00:00:00 GMT

The completion of the first implants of the Zenith TX2 Low Profile TAA Endovascular Graft (Cook Medical) took place in May 2010, as part of a clinical investigation, by assistant Professor Piotr Kasprzak, head of vascular surgery at the University Hospital Regensburg, Germany.

At 16F or 18F, the TX2 Low Profile delivery system is smaller than a standard TX2 device and is engineered to allow patients with challenging anatomies to be treated percutaneously. As a result, patients who previously may not have been suited to thoracic endovascular repair, for example those with narrowed, small or tortuous arteries, may now benefit from minimally invasive treatment.

Up to ten medical centres across Europe may take part in the TX2 Low Profile TAA study. Kasprzak said: “Treating an aneurysm with the TX2 Low Profile TAA from Cook Medical shows great promise. With this stent we’re able to treat patients with TEVAR. The TX2 Low Profile may provide a viable alternative to open surgery that may result in lower risks of complications to a larger patient population.”

New trial results on ExoSeal support its clinical safety and efficacy

Tue, 01 Jun 2010 00:00:00 GMT

The new ExoSeal vascular closure device (Cordis) received CE mark in May 2010 and was recently launched at the EuroPCR meeting in Paris. The company states that it incorporates a number of new advances in technology and simplicity of design to provide precise and secure extravascular arterial closure. The new product was shown in a recent clinical trial to have an “excellent” clinical safety profile (in terms of vessel injury, access site-related bleeding, infection or nerve injury, new ipsilateral lower extremity ischaemia or serious adverse events [SAE]) during vascular procedures.

The ExoSeal device makes use of key technological developments to support the clinical safety of the closure procedure. The bioabsorbable polyglycolic acid (PGA)-plug, is fully reabsorbed in 60–90 days. According to Cordis, a system of deployment through the existing procedural sheath makes ExoSeal quicker and easier to use and increases physician convenience by minimising or eliminating the need for sheath exchange during the procedure. The device uses visual indicators to help the clinician deploy the device correctly. This ‘visual feedback’ also promotes patient comfort during deployment and the 'lock-out' system of ExoSeal helps ensure that only extra-vascular plug placement can take place.

ECLIPSE Trial

The safety and effectiveness of the ExoSeal was assessed in two non-randomised studies conducted in Mexico and Germany, as well as a study in the US where the 6F ExoSeal was compared with manual compression (MC) with a 2:1 randomisation in patients undergoing diagnostic and interventional coronary/peripheral procedures. The trials tested the time to haemostasis, the time to ambulation and the 30-day combined rate of access site-related complications. The results showed that there were no major adverse events, no vascular repair, no access site-related bleeding requiring transfusion, no access site-related infection requiring treatment, no new ipsilateral low extremity ischaemia and no surgery for access site-related nerve injury.

The trial recorded no adverse clinical events and achieved a level of safety comparable to manual compression while significantly reducing time to ambulation. The device has achieved this level of clinical safety by combining easy-to-use functionality with trusted bioabsorbable technology and precise extravascular closure.

INNOVATION trial: First patients enrolled in study of new stent graft system to treat AAA

Tue, 01 Jun 2010 00:00:00 GMT

The first patients have been enrolled in the INNOVATION trial, which will assess the safety and performance of a new stent graft system, the Incraft (Cordis), to treat abdominal aortic aneurysm (AAA).

The Incraft’s delivery system features a low-profile that is made possible by using an integrated sheath of braided construction. The outer diameter of the integrated delivery system, which includes the device and sheath is 14F, whereas currently available endovascular aneurysm repair (EVAR) devices have system profiles ranging from 18 to 24 F.

The INNOVATION trial is a multi-centre, open-label, prospective, non-randomised study assessing the Incraft system in subjects with AAA. It will enrol up to 25 patients in three sites throughout Germany.

According to trial investigator Professor Giovanni Torsello, Chief of Vascular Surgery at St Franziskus Hospital, Muenster, “I am pleased to be a part of the INNOVATION trial. The ability to customise the Incraft system during the procedure is a very helpful feature for clinicians.”

The initial procedures using the system were performed by principal investigator Professor Dierk Scheinert, head of the Department of Medicine, Angiology and Cardiology at Park-Krankenhaus Hospital in Leipzig. Scheinert commented, “We have been excluding a significant portion of our AAA patients, especially women, from EVAR because current stent grafts have large and bulky delivery systems, making device introduction impossible for small or diseased access vessels. The ultra-low profile delivery system of Incraft will make EVAR a possible treatment alternative for a wider range of patients.”

Mynx M5: Designed specifically for 5F closure

Tue, 01 Jun 2010 00:00:00 GMT

AccessClosure has introduced its newest addition to the Mynx family, the Mynx M5 vascular closure device. Designed specifically for 5F closure, the Mynx M5 delivers an extravascular, conformable sealant through the existing 5F procedural sheath, eliminating the need for a sheath exchange and preserving the size of the arteriotomy. In addition, the Mynx M5 provides all the same benefits as the 6/7F Mynx. The device is deployed gently, avoiding cinching and tugging of the artery. Without the use of a suture or permanent metal implant, the Mynx sealant is placed on the surface of the artery.

According to the company, it immediately seals both the arteriotomy and the tissue tract, rapidly absorbing blood and subcutaneous fluids and minimising ooze. The Mynx sealant then dissolves completely through hydrolysis within 30 days. Furthermore, the company explains that the Mynx design minimises the discomfort commonly associated with vascular closure due to its deployment method and sealant material. It also uses a soft, bioabsorbable polymer sealant material, polyethylene glycol.

The Mynx Study
The Mynx study was a prospective, multi-centre, non-randomised clinical investigation conducted at five European centres. Patient enrollment included 190 patients with 50% of patients having undergone diagnostic catheterisation and 50% interventional procedures.

The primary safety endpoint was the combined rate of major complications within 30 days. The primary efficacy endpoints were time to haemostasis and time to ambulation.

Key results from the Mynx Study:

0.5% rate of major complications
Absence of complications requiring surgical repair
Rapid haemostasis (mean 1.3 minutes) independent of anticoagulation
Time to haemostasis comparable whether the patient underwent a diagnostic (median 0.5 minutes) or interventional (median 0.6 minutes) procedure
Consistently rapid time to ambulation of 2.0 hours for diagnostic patients and 1.9 hours for interventional patients

Mynx Study conclusions:

Demonstrated safety and efficacy
Extravascular, water-soluble sealant offering unique safety profile
Rapidly resorbs, leaving nothing behind
Potential for clinical versatility – PVD, immediate restick, obesity

Mynx M5 One Hour Ambulation Study
Commencing in March 2010, the Mynx M5 One Hour Ambulation Study (official title: ‘Single-centre, Post Market, Prospective, Consecutive, Single-arm Study Compared to Historical Control [Diagnostic Arm of the Mynx 6/7F Study]’), will assess the safety and tolerability of participants ambulating within one hour of placement of the Mynx M5 closure device. Participants will be assessed for adverse event occurrence for 30 days. The study is expected to be completed in August 2010.

SPACE and EVA-3S: CAS fails to meet criteria for non-inferiority in comparison with CEA

Tue, 27 Apr 2010 00:00:00 GMT

Results from the Stent-Supported Percutaneous Angioplasty of the Carotid Artery vs Endarterectomy (SPACE) trial and the Endarterectomy vs Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S), showed that carotid stenting failed to meet criteria for non-inferiority versus endarterectomy, and showed slightly higher rates of ipsilateral ischaemic stroke and death at 30 days.

However, longer-term follow-up of both trials, presented at last year's European Stroke Conference (2009), showed rates of ipsilateral stroke were low and similar between carotid stenting and endarterectomy groups at two and four years of follow-up.

According to SPACE investigator Dr Peter A Ringleb, rom Ruprecht-Karls-University, Heidelberg, Germany, “The conclusion from the SPACE trial is exactly the same as the EVA-3S study; that is, if a patient has been treated successfully without any complications, the [long-term] risk of a secondary stroke is very small and very comparable between these two modalities.”

SPACE Trial

The SPACE trial was a multi-national, prospective randomised study that aimed to test the hypothesis that CAS was not inferior to CEA for the treatment of patients with severe symptomatic carotid stenosis of >70%. A total of 1,214 patients were randomised to carotid angioplasty with stenting (n=613) or CEA (n=601). Thirty-day results from this trial did not prove non-inferiority of CAS compared with CEA.

Two-year results showed that in both intention-to-treat (ITT) and per-protocol analyses, Kaplan-Meier estimates of ipsilateral ischaemic stroke up to two years after the procedure and any periprocedural stroke or death were similar between the groups.

It was reported that restenosis of 70% or greater was significantly more common in the stenting group, again in both ITT and per-protocol analyses. However, only two cases of restenosis were associated with neurological symptoms, the authors noted. Although the incidence of restenosis was higher, they add, “it cannot be excluded that the degree of in-stent stenosis is slightly overestimated by conventional ultrasound criteria.”

The authors concluded, “Patients who were successfully treated with stent-protected angioplasty had a similar low risk of secondary cerebrovascular events as patients who were treated with endarterectomy, indicative of the similar preventive ability of endarterectomy and carotid angioplasty with stenting.” They added, “To assess the long-term effects, and particularly the effect of restenosis, most investigators agreed to collect follow-up data for up to five years after the initial study protocol had ended.”

EVA-3S

The EVA-3S trial was also a randomised non-inferiority trial comparing CAS with CEA in 527 patients with carotid stenosis of 60% or more that had recently become symptomatic. The trial was stopped early due to a higher risk of any stroke or death within 30 days of the procedure, and the main results published within a week of those of the SPACE trial in 2006.

In a recent paper, the EVA-3S investigators, with lead author Dr Jean-Louis Mas, HÃ´pital Sainte-Anne, Paris, France, reported on follow-up of these patients out to four years. They found that the cumulative probability of periprocedural stroke or death and non-procedural ipsilateral stroke was still higher among those in the stenting group versus endarterectomy.

However, the authors explained that a hazard function analysis showed that the differences in cumulative outcomes between stenting and endarterectomy were largely accounted for by events that occurred within 30 days of the original procedure. They explained, “After the periprocedural period, the risk of ipsilateral stroke was low and similar in both treatment groups.”

To conclude, the authors stated, “The safety of carotid stenting needs to be improved before it can become a widespread alternative to carotid endarterectomy in patients with symptomatic carotid stenosis.”

DEFINITIVE AR pilot study: Combining DEB with the TurboHawk device

Tue, 27 Apr 2010 00:00:00 GMT

ev3 recently announced the launch of the TurboHawk system for use in all plaque morphologies, including calcified lesions. Based on their SilverHawk peripheral plaque excision system, which was originally cleared for use by the FDA in 2003, the TurboHawk incorporates changes in the geometry and material of the cutter structure to treat calcified lesions that may be resistant to conventional treatment.

According to the company, the TurboHawk features a cutter blade with four angled breakers for added performance when addressing all plaque morphologies, a catheter jog to provide consistent cutter apposition force, and a newly designed drive shaft to improve cutting efficiency. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device.

DEFINITIVE AR study

Medrad Interventional/Possis announced the initiation of a supply agreement with ev3 for Medrad to provide its Cotavance peripheral drug-eluting balloon (DEB) angioplasty catheter with Paccocath drug technology for study in combination with ev3’s SilverHawk and TurboHawk plaque excision systems in the DEFINITIVE AR European pilot study for treating lower extremity peripheral arterial disease.

The DEFINITIVE AR study is a prospective, multi-centre, randomised pilot study evaluating the use of either the TurboHawk or SilverHawk systems followed by treatment with the Cotavance drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease. The pilot study will evaluate up to 125 patients in Europe and is anticipated to begin in the second half of 2010. The companies anticipate that a global, multi-centre, pivotal trial will follow the completion of the pilot study. Professor Thomas Zeller, MD, and Professor Gunnar Tepe, MD, will lead the study.

According to Tepe, “Drug-eluting balloons with Paccocath technology demonstrated encouraging safety and efficacy results in the THUNDER and FemPac trials. However, I believe that treatment outcomes could be improved by first removing plaque from the vessel with plaque excision prior to using a drug-coated balloon. The combination of TurboHawk or SilverHawk plaque excision followed by the use of the Cotavance balloon catheter may allow for enhanced drug uptake and an improved acute result and durability in the treated vessel.”

ICCS: Interim results show surgery is preferable to stenting

Tue, 27 Apr 2010 00:00:00 GMT

An interim safety analysis of the ongoing International Carotid Stenting Study (ICSS) offers strong evidence that carotid endarterectomy (CEA) is preferable to carotid stenting (CAS). ICSS investigators assessed the effectiveness of stenting and endarterectomy at preventing stroke, death, and procedure-related heart attacks in 1,713 patients with recently symptomatic carotid stenosis. Patients were randomly assigned to stenting (n=855) or surgery (n=858) and followed for up to 120 days after randomisation.

Findings showed that patients in the stent group had a significantly greater risk of stroke, death, or procedure-related heart attack within 120 days of randomisation –absolute risk 8.5% compared with 5.2% in the surgery group. Additionally, within 30 days of treatment the rate of stroke or death in the stent group was nearly twice the rate recorded in the surgery group. According to the authors, this difference was mainly due to a higher number of non-disabling strokes recorded in the stent group (36 versus 11 within 30 days of treatment), whereas the number of disabling strokes or deaths did not differ significantly (26 versus 18).

The authors concluded that, “Completion of long-term follow-up is needed to establish the efficacy of treatment with a carotid artery stent compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for symptomatic patients suitable for surgery.”

EVAR 1 and 2: 10-year follow-up results published

Tue, 27 Apr 2010 00:00:00 GMT

Principal investigator Professor Roger Greenhalgh, and trial manager Louise C. Brown, recently presented the 10-year follow-up results from the UK’s EVAR 1 and EVAR 2 trials of endovascular aneurysm repair (EVAR) versus open repair of abdominal aortic aneurysm (AAA) at the 2010 Charing Cross International Symposium, London. The findings were also published online ahead of print in the New England Journal of Medicine. EVAR 1 studied patients deemed fit for open surgical repair, and EVAR 2 studied patients deemed unfit for open surgical repair.

EVAR 1 demonstrated a significantly lower operative mortality than open surgical repair of AAA, however, the investigators concluded that no differences were seen in total mortality or aneurysm-related mortality in the long-term. EVAR was also associated with increased rates of graft-related complications and reinterventions and was more costly.

As explained in an article published in Endovascular Today, the study was composed of 1,252 patients presenting with large AAAs (≥5.5cm in diameter) at 37 hospitals in the UK from 1999 through 2004. The investigators randomly assigned the patients to undergo either EVAR or open repair; 626 patients were assigned to each group. Patients were followed for rates of death, graft-related complications, reinterventions, and resource use until the end of 2009. Logistic regression and Cox regression were used to compare outcomes in the two groups.

The investigators reported that the 30-day operative mortality was 1.8% in the EVAR group and 4.3% in the open repair group. The EVAR group had an early benefit with respect to aneurysm-related mortality, but the benefit was lost by the end of the study, at least partially because of fatal endograft ruptures. By the end of follow-up, there was no significant difference between the two groups in the rate of death from any cause. The rates of graft-related complications and reinterventions were higher with EVAR, and new complications occurred up to eight years after randomisation, contributing to higher overall costs.

In the EVAR 2 study of AAA patients who were physically ineligible for open repair, the investigators found that EVAR was associated with a significantly lower rate of aneurysm-related mortality than no repair. However, EVAR was not associated with a reduction in the rate of death from any cause. Also, the rates of graft-related complications and reinterventions were higher with endovascular repair, and it was more costly than not intervening.

EVAR 2 was composed of 404 patients considered ineligible for surgery presenting with large AAAs (≥ 5.5cm) at 33 hospitals in the UK from 1999 through 2004. The EVAR 2 investigators randomly assigned the patients to undergo either endovascular repair (n = 197) or no intervention (n = 207). Patients were followed for rates of death, graft-related complications, reinterventions, and costs until the end of 2009. Cox regression was used to compare outcomes in the two groups.

The EVAR 2 investigators found that the 30-day operative mortality was 7.3% in the EVAR group. The overall rate of aneurysm rupture in the group with no intervention was 12.4 per 100 person-years. Aneurysm-related mortality was lower in the EVAR group. This advantage did not result in any benefit in terms of total mortality. A total of 48% of patients who survived EVAR had graft-related complications, and 27% required reintervention within the first six years. During eight years of follow-up, endovascular repair was considerably more expensive than no repair.

According to Matt Thompson, St. George’s Hospital, London, “The most significant new finding of these trials was the lower rate of aneurysm-related death in the patients considered unfit for open surgical intervention (EVAR 2) and suggests a benefit to endovascular repair in these patients. The interpretation of the trials, and in particular the reintervention rates, must be done with the knowledge that the trials reflect the state of endovascular practice at the time of patient entry into the trials a decade ago.”

ARMOUR study: MO.MA device is safe and effective for patients at high surgical risk for CEA who undergo CAS

Tue, 27 Apr 2010 00:00:00 GMT

New research presented at the recent Society of Interventional Radiology (SIR) Meeting in Tampa, Fl, revealed that use of a new cerebral protection device in combination with carotid stents in high surgical risk patients provides a minimally invasive, safe and effective way to prevent stroke from occurring.

The MO.MA proximal embolic cerebral protection device (Invatec) acts as a balloon occlusion ‘endovascular clamping’ system to achieve cerebral protection prior to crossing the carotid stenosis. The device consists of a catheter with two compliant balloons at its distal portion, which can be independently inflated and deflated. A central lumen allows advancement and usage of the interventional devices (PTA balloons and carotid stents). The MO.MA device effectively reduces and captures debris released during the stenting procedure to prevent it from travelling to the brain, where it has the potential to cause a stroke. It is designed to achieve cerebral protection by proximal blood flow blockage at the carotid bifurcation: antegrade and retrograde flow blockage are achieved by proximal balloon occlusion of the common carotid artery (CCA) and distal balloon occlusion of the external carotid artery (ECA), respectively. Cerebral protection is thus established prior to the initial wire passage through the stenosis and maintained during the entire procedure. The MO.MA provides withdrawal of embolic particles by allowing manual syringe aspiration of any micro-emboli at the end of the procedure before restoring blood flow through the stented vessel.

ARMOUR clinical trial results

The results of the pivotal, multi-centre, non-randomised ARMOUR trial demonstrated the safety and effectiveness of MO.MA proximal flow blockage cerebral protection device for patients at high surgical risk for carotid endarterectomy (CEA) undergoing carotid artery stenting (CAS). In the prospective study, 262 patients were enrolled at 25 investigational sites in the US (20) and the EU (5) between September 2007 and February 2009. All study participants underwent percutaneous revascularisation of the carotid artery using the MO.MA device and a stent approved by the FDA for carotid artery stenting.

Primary outcome measures were major adverse cardiac and cerebrovascular events (MACCE) within 30 days of implantation. Secondary outcome measures were device success, technical success, procedural success, restenosis at 30 days, and target lesion revascularisation (TLR) at 30 days.

For the intention to treat population (n=225), the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians, and device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. The mortality rate was 0.9%, and there were no myocardial infarctions. The device success for the MO.MA was 98.2%, technical success 94.6%, and procedural success 93.2%. The access site complication rate was 3.1%.

The trial investigators stated that the absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multi-centre registry trial to date.

Dr L Nelson Hopkins, State University of New York, Buffalo, US, and co-principal investigator of the ARMOUR trial stated, “Proximal embolic protection is an important advance that gives us more options in the treatment of carotid artery disease. The MO.MA Ultra combines the advantages of carotid endarterectomy with the minimally invasive benefits of carotid artery stenting.”

He added that, contrary to popular opinion, the device is easy-to-use, device intolerance is rare and usually reversible and, as confirmed by magnetic resonance and transcranial Doppler imaging, less emboli travel to the brain. Hopkins said that it appears as if proximal embolic protection may be the procedure of choice for recently symptomatic patients, low gray-scale measure lesions, and perilesional tortuosity. This technology may also prove useful for string sign lesions, acute carotid occlusion/stroke, and luminal thrombus in the future.

“These results confirm the safety and effectiveness of the MO.MA device for proximal protection in high surgical-risk patients, and the cumulative event rate compares very well with the other trials,” he concluded. “I like to think of this as an endovascular endarterectomy. The procedure shuts down all the vessels, removes or pushes aside the plaque, and then aspirates out all the debris, much like we do with an endarterectomy. As a result, we have the advantages of the endarterectomy combined with the benefits of a minimally invasive procedure and short occlusion times for the patient.”

UFE and myomectomy show similar fertility rates

Tue, 27 Apr 2010 00:00:00 GMT

Uterine fibroid embolization (UFE) has a comparable fertility rate to myomectomy, the surgical removal of uterine fibroids, for women who want to conceive, according to the first study on the subject released at the recent SIR meeting.

“This study is significant because it shows comparable fertility rates between the two primary uterussparing treatments widely available to treat fibroids: UFE and surgical
myomectomy, which is considered the gold standard for symptomatic fibroids in women who wish to conceive,” said Dr João Martins Pisco, St Louis Hospital, Lisbon, Portugal. “These results are surprising because other studies have favoured surgical myomectomy over UFE for women who want to conceive.”

In the study of 743 women, UFE had a fertility rate of 58.1%, which is comparable to surgical fibroid removal (myomectomy), which has a fertility rate of 57%, explained Pisco.

“Our study proves that UFE not only allows women who were unable to conceive to become pregnant but also allows them to have normal pregnancies with similar complication rates as the general population in spite of being a high risk group,” he added. “In the future, UFE will probably be a first-line treatment option even for women who wish to conceive and are unable due to the presence uterine fibroids,” he noted.

EVAR, DREAM, ACE and OVER trial updates

Tue, 27 Apr 2010 00:00:00 GMT

At the recent LINC meeting, Leipzig, Germany, Louise Brown presented an overview of the results from several endovascular aneurysm repair (EVAR) versus open repair trials in fit patients anatomically suitable EVAR. She presented the results from the EVAR 1 (UK), DREAM (Netherlands), ACE (France) and OVER (US) trials.

In regards to recruitment two of the trials, OVER and EVAR 1 recruited the target number (EVAR 1 target number – 900, final number– 1,252; OVER target number –872, final number – 881), whereas the DREAM and ACE trials did not achieve their recruitment targets (DREAM target number – 400, final number –351; ACE target number – 600, final number – 306).

Brown reported that there were noted patient differences between the trials. For example in the EVAR 1 trial the mean age was 74 years, whereas in the DREAM and
OVER trial the mean age was 70 years. In the EVAR 1 and DREAM trial 90% of patients were male and in the OVER trial 99% were male. The mean AAA size in the
EVAR 1 trial was 6.5cm, but was lower in the DREAM (6.1cm) and OVER (5.7cm) trials. There were also differences in aspirin use between the trials (DREAM [40%], EVAR [53%] and OVER [59%]. Finally, there were also differences between the trials in the type of stent graft device utilised (EVAR, DREAM: Zenith/Talent/Gore- OVER: Zenith/Gore/AneuRx).

“However, despite these differences, the results show a clear consensus on operative mortality,” said Brown. Other results across the trials showed a similar two year survival rate of approximately 85–90%, although the OVER trials showed a lower AAA-related mortality. In addition, there were no differences for erectile dysfunction, health related quality of life scores and the trials reported similar overall costs. However, complications and re-interventions differences were difficult to ascertain due to differing reporting protocols and cost effectiveness decisions vary between the trials.

Interestingly, there were differences between the trials in regards to all cause mortality catch up (the point at which the all-cause mortality rate between both EVAR and open repair groups was the same).

For example, in the EVAR 1 trial the catch up was recorded at two years after randomisation (Lancet 2005;365: 2179-86); in the DRAM trial the catch up was recorded at 12 months (NEJM 2005; 352: 2398-405); however in the OVER trial no catch has been recorded at two years (JAMA 2009; 302: 1535-1542). Moreover, Schermerhorn et al (NEJM 2008; 358: 464-74) reporting US Medicare data have shown all-cause mortality catch-up (from 45,660 patients) at three years.

Additional insights from these trials will be available in the coming months with the long-term results from the EVAR 1 and DREAM trials reporting later in 2010. The early-mid term results from the ACE trials are to be published imminently, with the long-term results from ACE and OVER to be published in 2012.

New TEVAR devices

Tue, 27 Apr 2010 00:00:00 GMT

Several devices are currently available to treat thoracic pathologies, differing with respect to design, metallic composition and structure of the stent, and presence or absence of an active method of fixing the device to the aortic wall.

RESCUE trial: Valiant device

Launched in October, 2009, the Captivia Delivery System for the Valiant Thoracic Stent Graft (Medtronic) is a minimally invasive treatment for aneurysms and other lesions of the thoracic aorta. The Captivia Delivery System features tip capture for enhanced control of the stent graft during deployment and a hydrophilic coating applied to the graft cover to facilitate iliac access and delivery through patients’ vasculature.

The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System for the Endovascular Treatment of Blunt Thoracic Aortic Injuries (RESCUE) study is currently recruiting patients and is expected to be completed by early 2011.The purpose of the study is to determine if the Valiant stent graft is safe and efficient in treating patients who have a blunt thoracic aortic injury (BTAI).

Primary outcome measures include all patients are alive (up to 30 days after implant) and secondary outcome measures are successful delivery and deployment of the stent graft, device, procedure and/or aortic related adverse events, and aortic related mortality (30 days after implant).

Patients included are those with a blunt thoracic aortic injury. Excluded patients include those who have received a previous stent or stent graft or previous surgical repair in the descending thoracic artery (DTA); have a history of bleeding diathesis, coagulopathy, or refuses blood transfusion; have a known allergy or intolerance to the device components; and have a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

TX2

Cook’s new TX2 Pro-Form endograft, which has now obtained FDA approval, utilises an improved delivery system that allows for carefully controlled deployment of the endograft to help establish proximal conformity of the device to the aortic wall.

At the recent CX Vascular conference, London, UK, Mr Matt Thompson explained, “The challenges in the deployment are to achieve stability in high haemodynamic forces, attachment and sealing in proximal sealing zone, conformability to difficult angulated arch and long-term resistance to migration. If there was a fault with some of the early designs it was with conformability and achieving a seal in that angulated area just at the level of the left subclavian artery, the recent Proform modification that slightly deforms the proximal stent and allows it to make early contact with the aorta is a significant advantage.”

Furthermore, “the TX2 should be used particularly for the sort situation when you have a descending thoracic aneurysm finishing just between the level of the superior mesenteric artery and the coeliac access. We want to deploy at the level of the superior mesenteric artery and have distraction forces constrained by the axial fixation disc,” said Thompson.

TAG

Gore recently announced the first human implants of the next generation Conformable Gore TAG Thoracic Endoprosthesis in the US for the treatment of traumatic transection of the thoracic aorta. The commercially available GORE TAG Thoracic Endoprosthesis is a minimally invasive option for safely and effectively treating patients with descending thoracic aortic aneurysms. It is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. It received pre-market approval from the FDA in 2005.

In addition to traumatic aortic transection, the next generation Conformable GORE TAG Device has been approved to investigate endovascular repair of other etiologies including thoracic aortic aneurysm and aortic dissection.

The Conformable Gore TAG Device Traumatic Aortic Transection Trial will investigate the treatment of patients with aortic diameters of 16–42 mm.

Initial experience with innovative new stent delivery system

Tue, 27 Apr 2010 00:00:00 GMT

Recently, the Department of Angiology at the Park Hospital, Leipzig, participated in the initial release of the SUPERA VERITAS Peripheral Vascular Stent delivery system. Compared to previous generations of SUPERA stent delivery systems, they experienced significant improvements and found that SUPERA VERITAS provides the operator with a smooth and controlled deployment of the SUPERA stent. The system also incorporates ease of use by significantly reducing the number of steps needed to prep and deliver the stent.

According to Dr Dierk Scheinert, Leipzig, Germany, “In our department we have been utilising the SUPERA stent clinically for over two years and we have been very impressed with the performance of the stent and positive clinical outcomes. Even in the most challenging anatomy, the SUPERA stent has delivered the strength and flexibility to accommodate the most challenging vessels in the femoropopliteal region. The interwoven nitinol stent is truly a differentiated platform that produces best in class radial strength without sacrificing flexibility or durability. In our experience we have learned that this differentiated platform requires different vessel preparation and sizing considerations compared to using ‘slotted tube’ stents.”

He further explained that it is important to prepare the vessel to the outer diameter of the stent and size the outer diameter of the stent 1:1 to the vessel. Due to the increased radial strength of SUPERA, there is no need to oversize the stent and doing so will actually compromise the performance and accuracy of the stent.

There are several ongoing studies to evaluate the clinical performance of SUPERA including the Leipzig Registry at Park Hospital and the SUPERB clinical trial.
In the Leipzig Registry, the researchers have follow-up on 107 patients with lesions in the superficial femoral artery (SFA) and 76 patients with popliteal obstructions treated with the SUPERA stent. The initial data shows high patency rates of >85% at 12 months in both locations and no fractures even in the popliteal segment.

“This is very exciting and I believe that this could be a ‘game changing’ technology for stenting in the peripheral space,” explained Scheinert.

The SUPERB (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) trial is a prospective, single-arm trial of 258 patients at up to 38 U. sites and two European sites. The objective of the trial is to demonstrate the safety and effectiveness of the SUPERA stent in the treatment of obstructive arterial disease in the superficial femoral artery of the lower extremity. This trial is currently enrolling patients.

In conclusion, Scheinert believes that the SUPERA VERITAS delivery system is much improved and provides smooth and easy delivery of the SUPERA stent. The SUPERA stent has proven to be a significant advancement in stent technology and its unique characteristics allow physicians to treat areas where standard ‘slotted tube’ nitinol stents have always encountered difficulty.

CREST: CEA and CAS similar in overall long-term safety and efficacy

Tue, 27 Apr 2010 00:00:00 GMT

The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), funded by the National Institute of Neurological Disorders and Stroke with supplemental funding by Abbott Vascular, is the largest randomised clinical trial comparing the CEA to the CAS to prevent stroke among patients with and without symptoms.

The RX ACCULINK Carotid Stent System (Abbott Vascular) was the stent used in the trial, and includes a self-expanding nickel-titanium stent pre-mounted on a rapid exchange stent delivery catheter. The delivery system is comprised of a retractable sheath covering the stent during delivery, a radiopaque tip, an internal guide wire lumen, a handle assembly with a safety lock, and a pullback handle. With the handle in the unlocked position, retracting the pullback handle removes the sheath and deploys the stent. Upon deployment, the stent forms an open lattice, providing the scaffolding necessary to hold the artery open and ensure blood flow through the artery.

The stent system is available in a range of stent lengths and diameters, and in straight and tapered configurations. Stent ends should be sized between the 1.1:1 and 1.4:1 stent-to-artery ratio. Tapered stents are designed to provide appropriate stent apposition when there is a distinct difference between vessel diameters at each stent end. The proximal stent end is sized to the common carotid artery (CCA) and the distal end is sized to the internal carotid artery (ICA).

According to lead investigator, Dr Thomas G Brott, Mayo Clinic, Jacksonville, Fl, “We found that the two procedures were similar with regard to the study’s primary endpoint – overall incidence of stroke, MI and death.” He added, “We also found that the rates of these events were low, and that safety for patients with and without symptoms was as good as any reported in any randomised carotid intervention trial.”

The primary aim of CREST is to contrast the relative effectiveness of CAS versus CEA in preventing stroke, MI, and death. Researchers randomised 2,502 patients – 35% were female and 9% minorities – to receive either CEA or CAS at more than 100 North American hospitals. More than 80% of the participants had an artery blockage greater than 70%.

The prospective, randomised, parallel, two-arm, multi-centre trial included patients who have experienced a transient ischaemic attack (TIA), amaurosis fugax (AF), or non-disabling stroke within the past 180 days, and who have an ipsilateral carotid stenosis >=50% by angiography or >=70% by ultrasound or >= 70% by CTA or MRA. Also included were patients who have carotid stenosis >=60% by angiography or >=70% by ultrasound or >= 80% by CTA or MRA.

Excluded patients included those who have comorbid conditions that interfere with the evaluation of endpoints, that are known to interfere with the completion of CEA or CAS, or that affect the likelihood of survival for the four-year study period.

Dr Brott and his colleagues found that in the 30-day period following the procedure, the rate for stroke was 2.3% in the surgical patients and 4.1% in the stenting group. However, the MI rate was higher in the surgical group, 2.3%, compared to 1.1% in the stenting group. The difference in MI and stroke between the two groups was statistically significant, explained Brott.

The researchers also found that the age of the patient made a difference in outcome. At approximately age 69 and younger, stenting results were slightly better, with a larger benefit for stenting, the younger the age of the patient. Conversely, for patients older than 70, surgical results were slightly superior to stenting, with larger benefits for surgery, the older the age of the patient.

Furthermore, researchers found that symptomatic and asymptomatic patients, and males and females, had similar outcomes in the surgical and stenting groups.

“For the present, stenting offers a reasonable alternative to carotid artery surgery,” Brott said. “For younger patients, carotid stenting appears to be a very useful tool,” he concluded.

ACT I Study

Tue, 27 Apr 2010 00:00:00 GMT

ACT I is comparing CAS with CEA for the treatment of asymptomatic extracranial carotid atherosclerotic disease. The study is being conducted to demonstrate the non-inferiority of CAS using the Emboshield Embolic Protection System and Emboshield Pro Embolic Protection System (Abbott Vascular) with the Xact-Carotid Stent System to CEA. An update was recently presented at the recent LINC meeting (Leipzig, Germany) by Dr John Laird, Davis, US.

The planned recruitment is 1,858 who will be randomised to a ratio of 3:1 (CAS: CEA). Patients are followed at 24 hours, 30 days, six months and annually up to five years post procedure. A neurological exam performed by an independent neurologist/neurosurgeon or NIHSS certified specialist at pre-enrolment, 24-hours and 30-days post-procedure, six-months and annually up to five years. To date, a total of 980 patients have been randomised.

The primary endpoint is composite death, stroke, myocardial infarction (MI) at 30 days post-procedure, plus ipsilateral stroke from 31 to365 days post-procedure. Secondary endpoints include death and ipsilateral stroke (years two-five years), cranial nerve injury, bleeding, vascular and/or wound complications requiring treatment, complications of general anaesthesia, access artery, renal and airway complications, freedom from clinically-indicated target lesion revascularisation
(TLR) at six and 12 months, acute stent success (residual stenosis <50% by QCA covering an area no longer than original lesion), acute filter success (successful deployment and retrieval of filter in absence of angiographic distal embolization and procedural success (residual stenosis <50% by QCA and freedom from major adverse event at 30 days).

Laird explained, “My prediction from the outcomes of ACT 1 would be low event rates in both groups, with no significant difference between CAS and CEA. This will be due to the use of experienced operators, a lower risk patient group, utilising newer generation devices. However, despite the low event rates, the trial will not convince neurologists that CAS or CEA is indicated for asymptomatic
carotid artery stenosis.”

New research shows vertebroplasty for patients with osteoporosis provides effective pain relief

Tue, 27 Apr 2010 00:00:00 GMT

At the recent Society of Interventional Radiology (SIR) meeting, new research showed that patient selection is key for vertebroplasty to be effective and successful. In a study of more than 1,500 patients who were followed over seven years, 2,251 osteoporotic patients (1,811 women; average age, 65) suffering from backpain for vertebral collapses (MRI confirmed) underwent a clinical interview.

Vertebroplasty was performed in 1,542 patients (1,302 women; average age, 73) when optimal medical treatment (such as biphosphonates, teriparatide, analgesics and back brace) did not help relieve pain or improve quality of life for patients over a three-month period. After vertebroplasty, patients continued to receive medical treatment with a rheumatologist.

In 1,494 patients (96.9%), the average pre-treatment pain score on the 11-point visual analog scale was 8.2±1.8, and it dropped significantly to an average of 1.1±1.6 after vertebroplasty treatment. The Oswestry Disability Questionnaire (ODQ) scores changed from an average of 68.7±7.6% to 18.5±8.2%. Long-term follow-up (average, 31.2 months) in 1,017 patients (857 women; average age, 72) showed the visual analog score (VAS) significantly dropping from 7.9±1.5 to 1.3±1.7. Of the 757 patients wearing a back brace before vertebroplasty, 683 could stop wearing one after treatment.

Lead researcher Dr Giovanni C Anselmetti, Institute for Cancer Research and Treatment in Turin, Italy, said additional studies need to be performed, such as a large randomised trial comparing conventional medical treatment to medical treatment plus vertebroplasty.

An overview of simulators

Wed, 10 Dec 2008 00:00:00 GMT

Introduction

A summary of the subjective opinions of Interventional Radiologists regarding selected medical simulations by WE Lewandowski and DA Gould.

This article aims to reflect the subjective opinions of Interventional Radiologists regarding the ability of medical simulators, manufactured by three different vendors, to replicate key procedural tasks in the carotid, contralateral iliac and renal arteries. The data obtained also provides feedback to the medical simulation industry on the opinions of Interventional Radiologists as to the realism and fidelity of aspects of the carotid, contralateral iliac and renal procedures in the various simulators. It is important to note that the data discussed in this article was collected during the period September – November 2006, and thus represents a snapshot in time regarding the capabilities of the various simulations discussed below. The authors are aware that all of the simulation manufactures have modified their products since the data was originally collected.

Background

Simulations of varying degrees of effectiveness have been developed to support training for a large number of medical specialties from anesthesiology to urethroscopy. Interventional Radiology is no exception with still-evolving simulations available from vendors in carotid, iliac and renal procedures. A critical factor in these simulations is presentation to the operator of visual cues in a virtual fluoroscopic image, challenging the operator’s decision making and procedural sequencing. Tactile cues are also perceived via a human-computer interface device which aims to replicate the subtle feel transmitted through guide wires, catheters, and other interventional devices in patients. Yet little is known about these low level cues and their importance in the many procedural steps that are performed automatically by the experienced operator.

A number of studies and papers have been presented in medical literature and society meetings analyzing the various aspects of medical simulation including efficacy, transfer of training and validation (1-8). In our opinion, however, what has not been done is to provide practical information to the Interventional Radiology community that would be immediately useful in the decision process as to how to integrate medical simulation into curricula.

By definition, a simulation is not reality; it is an imperfect reflection. While modern technology has made amazing advances in its ability to replicate complex aspects of reality such as tissue deformation, fluid dynamics and touch (9), at least for the foreseeable future, the fidelity of sensory reproduction in medical simulation will not be the equivalent of sensory experience in reality. Because of this, there will be some aspects of a simulated procedure that will be less than acceptable for training. Conversely, there will be other aspects of the procedure that will be considered adequate.

In this study (September – November 2006) we relate aspects of the medical simulation experience that have been considered by subject matter experts (SME) to be acceptable in simulators manufactured by three different vendors (10-12). There follows a description of each of these simulators as they existed during the period September to November 2006.

CathLabVR™

The CathLabVR™ Surgical Simulator (formerly the Endovascular AccuTouch® System: Immersion Medical, Gaithersburg, UA) is claimed to demonstrate capability to “allow clinicians to practice coronary, carotid and peripheral vascular interventions, cardiac pacing, and cardiac valve replacements. The CathLabVR virtual reality system, which simulates the look and feel of actual surgeries, helps clinicians to develop skills prior to performing on patients and to maintain those skills throughout their professional practice” (10). At the time of this study, the CathLab simulation we used demonstrated a range of cases scenarios in one anatomical region, the Carotid artery, in support of Interventional Radiology, carotid stent training.

Procedicus VIST – Radiology simulator

Procedicus VIST^TM – Radiology simulator

Mentice, a Swedish-based medical simulation company, manufactures an endovascular simulator called the Procedicus VIST^TM – Radiology simulator. At the time of the study (September – November 2006), Carotid, Iliac and Renal simulations were available to support Interventional Radiology.

The VIST system claims: “highly realistic simulation based training of renal, carotid and iliac stenting using realistic 3D patient anatomies, real nested tools, tactile feedback, different cases /scenarios and complications. The Procedicus VIST^TM system consists of an interface device, a computer and two displays - one for the fluoroscopic image and one for the instructional system. The interface device is the virtual patient, with an introducer in place. Through this, the different real life tools and devices can be introduced - actual tools are used (and are re-used). All tools are active and can be manipulated at any time in the procedure. The interface and the tools (catheters, balloons, guide wires, etc.) interact with the simulation through a software package generating the fluoroscopic display, the forces that are reflected in the tools (for tactile feedback), the contrast flow, hemodynamics and the results of the simulated intervention. The web based user interface guides the user through the procedure and facilitates for self-learning” ⁽11).

ANGIO Mentor™ simulator

Simbionix is a US-based medical simulation company that manufactures an endovascular simulator called the ANGIO Mentor™ simulator. At the time of the study (September – November 2006), it had Carotid, Iliac and Renal simulations to support Interventional Radiology.

For the ANGIO Mentor™, Simbionix claims that it is designed “ … to enhance skills across the range of invasive percutaneous cardio/endovascular techniques, including diagnostic angiography, angioplasty intervention, administering thrombolytic agents, and capabilities for recognition and management of developing complications. The use of the ANGIO Mentor™ simulator by interventional cardiologists and radiologists results in a higher level of professional skills, allowing them to provide patients with better care”(12).

Clinical findings/procedure details

This proposal has been part funded by a grant from CIRSE Foundation and commenced with an abbreviated task analysis for each of the target procedures. The procedural task analyses were then sent to representatives of each of the simulator manufacturers for their concurrence that the task analyses reasonably reflected those aspects of the target procedures the various simulators were designed to simulate. Next, the task analyses were sent to Interventional Radiologists, recommended by CIRSE, for review. The final task analyses were then combined with questions on respondents’ biographical backgrounds and converted into a survey. The draft surveys were then sent to the CIRSE review panel for final concurrence.

The survey was primarily conducted at the September 2006 CIRSE meeting in Italy, and then again at the smaller November 2006 BSIR meeting in England. These meetings were chosen to take advantage of the wide range of Interventional Radiologists in attendance. At both of those meetings, the medical simulation vendors had been invited to set up their devices in an area set-aside for that purpose (Immersion Medical was not present at BSIR). Meeting attendees were requested to use the various simulators, dependent on the time available, and to then complete the surveys. An area was designated to return completed surveys.

Respondents were self-selecting, and free to use any, or all, of the simulators as often as they desired: no effort was made to control the actions of the respondents and not every respondent chose to review all three simulators. During their use of each simulator, they were assisted either by a vendor’s technical supporter or by another conference attendee.

The completed surveys were collected, collated and analyzed by the authors. The survey is reproduced below with the participants’ collated responses, embedded. Black text represents the survey itself as seen by the participants. The various colored graphs, and the red text are the collective responses. Where comments were provided by the respondents, they have been recoded here without editing.

SURVEY (WITH RESULTS) DISTRIBUTED AT CIRSE CONFERENCE SEPTEMBER 2006 AND BSIR NOVEMBER 2006

General Biographical Information (26 respondents)

1. Years in Interventional Radiology (or other interventional) Practice?

Median 13 years +/- 9.23

2. Age? _

Median 45 years +/- 8.46

3. What is your gender?

Male = 24, Female = 2.

4. In what country or countries are you licensed to practice medicine?

5. How would you describe your level of experience with the use of computers?

Very experienced: 42%

Somewhat experienced: 58%

6. Have you used a medical simulator in any type of training program?

Yes: 15

No: 11

If you have answered “Yes” please provide details:

‘Previous Simulation [?]’

‘During the French annual congress. During a renal interventional procedure training.’

‘Guidant JFR 2003’

‘Clinical decision making in trauma patients (theoretical simulation).’

‘In a Cordis training program’

‘STUD+, DATS, Congress’

‘Guidant renal simulation in Brussels’

‘Saw and tried a surgical model. Carotid stent Mentice.’

‘Mentice, Simbionix, MSC and Immersion’

7. In the chart below, please write in the year you started performing the indicated procedures:

8. In the chart below, please indicate when you trained to perform the following procedures:

9. In the chart below, please indicate how many of the following procedures you perform in a year:

Carotid Procedure – The Immersion Medical Simulation

10. The tasks below are those generally associated with performing a Carotid Procedure. Please indicate the degree to which you either agree or disagree that the Immersion Medical simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 1

Comments:

“Has complications - good. Has adjunct drugs - good. Stable machine.”

“Not very realistic. Doesn't exchange guidewires, catheters only pull back 10-20 cm. Uses same catheters/guidewires[?] realism of exchanging.”

“The machine crashed during the procedure.”

Carotid Procedure – The Mentice Simulation

11. The tasks below are those generally associated with performing a Carotid Procedure. Please indicate the degree to which you either agree or disagree that the Mentice simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

Table 2

Comments:

“Mentice simulation vessels look less than Simbionix. Spontaneous catheter movements in desc. Aorta without manipulation. Report after procedure less than Simbionix. Auto centering option is great feature.”

Contralateral Iliac Procedure – The Mentice Simulation

12. The tasks below are those generally associated with performing an Iliac Procedure. Please indicate the degree to which you either agree or disagree that the Mentice simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 3

Comments

“Wire too long. Makes exchanges awkward and unrealistic.”

“Face validity issues. Air in syringe. Stiff wire end.”

Renal Procedure – The Mentice Simulation

13. The tasks below are those generally associated with performing a Renal Procedure. Please indicate the degree to which you either agree or disagree that the Mentice simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 4

Comments:

“Good sensations but sometimes a too important moving of the catheter not the stent despite a gentle push through.”

“Every diagnostic aspect of the procedure is realistic. The intervention part maybe emphasize a little bit too much the tricky part (i.e. stent sliding forward or backward. The manual feeling is rather realistically rendered. Good tool to help student to understand the preliminary explanation. Very favorable opinion.”

“Have not done renal stent procedure so my comments about realism should be guarded. Excellent idea to get familiarity with tasks. Not perfect for feel of wire.”

Carotid Procedure – The Simbionix Simulation

14. The tasks below are those generally associated with performing a Carotid Procedure. Please indicate the degree to which you either agree or disagree that the Simbionix simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 5

“Procedure should also include realistic exchange of wires. Software not yet "stable" (two lock ups).”

“Very easy exchange device. Good ? Can give drugs. Has complications. Excellent report.”

“Choice of devices is limited. I did not find the catheters/stents I use. But on the whole a very sophisticated and advanced system. I liked the additional medical [?] (drugs, vital signs, etc.) The patients [?]”

“Not bad”

Contralateral Iliac Procedure – The Simbionix Simulation

15. The tasks below are those generally associated with performing an Iliac Procedure. Please indicate the degree to which you either agree or disagree that the Simbionix simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 6

Comments

None

Renal Procedure – The Simbionix Simulation

16. The tasks below are those generally associated with performing a Renal Procedure. Please indicate the degree to which you either agree or disagree that the Simbionix simulator realistically simulates a particular task by circling the appropriate number (1= strongly disagree; 2= somewhat disagree; 3= acceptable; 4= somewhat agree; 5= strongly agree). If you feel that a given task is not simulated at all, please circle “NA”.

TABLE 7

Comments:

“Not bad”

“A not good machine with [?] helping people.”

Conclusions

42% of the respondents reported that they had previously used a simulator in a training program, a higher proportion than we had expected. It was also informative that a significant percentage of respondents reported that they performed less than 10 of the targeted procedures per year.

In the task analysis, respondents tended to feel that those aspects of the simulation which were mostly based on cognitive skills (i.e. rules, concepts, discriminations and decision making) were simulated to an acceptable level, while those requiring fine motor skills and response to subtle changes in touch and pressure tended to be scored to a lower level of acceptability. This varied non-significantly between simulators but confirmed our expectations as to respondent’s views on fine motor actions.

As the reader reviews the results of this study, it is important to remember that this is a “snapshot” in time. It is expected that, since this study was conducted, the characteristics and capabilities of the various simulators have changed. It is also important to note the circumstances under which the survey was conducted. Medical conferences tend to be hectic affairs in which focus and concentration are very limited. On the other had, we do feel that there is some value in impressions that are gained without extensive processing.

It is our hope that the data we have presented will be useful in helping institutions to identify how the subject medical simulators might be useful as tools for teaching selected procedural aspects of Interventional Radiology in resident and fellowship programs. We feel that even though the functionality and capabilities of the simulators used in this study has changed, the data still has relevance since a number of institutions own the type and model of devices that were used in this study. In addition, we feel that the study can serve as a useful guide for evaluating current and future simulation devices. The format we use allows the reader to look at specific, key procedural tasks and review the grading of relative effectiveness of a particular simulator to realistically replicate a given task. We also feel, that it provides some valuable information back to the vendors as to what aspects of their simulation they may want to improve.

The fact that the respondents tended to feel that the simulators were not as realistic in simulating fine motor skills, as they were in simulating cognitive skills, should not be construed in too negative a light. As important as the fine motor skills are, the cognitive skills are equally a part of the procedures and are thus equally important. They too must be mastered to be able to successfully perform a procedure. Perhaps the conclusion that should be drawn is that for the cognitive skills the various simulators might be relied upon as important training devices, but at least for the specific model of simulators used in this study, this might not be the case for acquisition and perfection of fine motor skills. While residents might be taught the procedural steps of these motor skills using a simulator, other means probably have to be relied upon in order to complete the learning process. These other means rely, for now, on mentored training in patients within apprenticeship training programs.

References

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2. Gallagher AG, Ritter M, Champion H et al. Virtual reality simulation for the operating room: proficiency based training as a paradigm shift in surgical skills training. Annals of Surgery, 2005; 241:364-372

3. Gould DA, Reekers JA, Kessel DO, Chalmers NC, Sapoval M, Patel AA et al., CIRSE. Simulation devices in interventional radiology: caveat emptor. Cardiovasc Intervent Radiol 2006 Jan-Feb;29(1):4-6.

4. Gould DA, Kessel DO, Healey AE, Johnson SJ, Lewandowski WE. Simulators in catheter based interventional radiology: training or computer games? Clin Radiol 2006;61:556-561.

5. Agarwal R, Black SA, Hance JR, Darzi A, Cheshire NJW. Virtual reality simulation can improve inexperienced surgeon’s endovascular skills. Eur J Endovasc Surg 2006;31:588-593.

6. Letter / comment: D Kessel, D Gould, W Lewandowski. Virtual Reality Simulation Training can Improve Inexperienced Surgeons’ Endovascular Skills. Eur J Vasc Endovasc Surg (Vol 33) Feb 2007: p259.

7. Hsu JH, Younan D, Pandalai S, Gillespie BT, Jain RA, Schippert DW et al. Use of computer simulation for determining endovascular skill levels in a carotid stenting model. J Vasc Surg 2004;40(6):1118e1124.

8. Dayal R, Faries PL, Lin SC, Bernheim J, Hollenbeck S, Derubertis B et al. Computer simulation as a component of catheter based training. J Vasc Surg 2004;40(6):1112e1117.

9. F. P. Vidal, F. Bello, K. W. Brodlie, D. A. Gould, N. W. John, R. Phillips, and N. J. Avis. Principles and Applications of Computer Graphics in Medicine. Computer Graphics Forum, Blackwell, 25(1):113–137, 2006.

10. Immersion Medical, Endovascular AccuTouch Simulator website: http://www.immersion.com/medical/products/endovascular/index.php. (accessed 24 June 2007).

11. Mentice Procedicus VIST-Radiology. Carotid and Renal stenting: website. http://www.mentice.com/. (accessed 24 June 2007).

12. Simbionix: ANGIOMentor: website. http://www.simbionix.com/ANGIO_Mentor.html. (accessed 24 June 2007).