Medical Devices Today

In Search of the Perfect Aortic Endograft

Why is the aortic endograft market so complex and challenging? Understand how endovascular aortic repair has struggled and how endovascular surgeons are forging ahead. Find out which companies have endografts in development and who to watch. Full article included with FREE ISSUE of Medtech Insight - Download Now.

Neurotechnology Needs Better Outcomes Measures, Diagnostics – VC Investors

Find how the development and regulatory approval of new drugs and devices for treating diseases of the brain is hindered by the inadequacy of existing diagnostics and outcome measures, according to venture capitalists who spoke at a recent neurotech industry forum.

Device Financings: Recent Growth, Future Opportunities

In Vivo analyzed recent public and private device financings to determine the comparative strengths and weaknesses of the various types of device financings, and further broke down the investments by therapeutic categories to examine what areas are hot and which ones are not.

Gainsharing Drives Down Device Prices, Study Shows

Find out why members of the device industry are saying that a controversial model could limit physicians' ability to choose certain products and does not adequately measure the effects on the quality of care.

China: The Wild, Wild East for Medical Devices

Explore the emerging opportunities for medical device companies in China... Find out why some analysts are predicting a compound annual growth rate of 15% over the next 10 years from a base of approximately $10 billion in 2007.

Helicon CEO Peter Abrahamson On Exploiting Niche Markets In China: An Interview With PharmAsia News

This exclusive interview is reprinted from PharmAsia News - May 27, 2008

Find out how one Australia-based company is making the most of the niche market opportunities in the specialty medical technology markets of China and North Asia in our exclusive interview with Helicon's CEO Peter Abrahamson.

Surgery for Diabetes? CMS Will Look At the Evidence For Coverage

Full article reprinted from "The Gray Sheet" - May 26, 2008

In response to media attention focused on bariatric surgery's potential to send diabetes patients into remission, a skeptical CMS said last week that it would consider whether a new national Medicare coverage policy was needed.

The national coverage analysis, opened May 19, will focus, in particular, on reviewing the evidence of the benefits of bariatric surgery in people with diabetes who are not considered morbidly obese by standard body-mass index (BMI) measures.

A CMS ¹tracking sheet announcing the coverage analysis says such evidence is "scant" and cites the American Diabetes Association as urging caution in attributing a benefit.

According to the American Society for Metabolic and Bariatric Surgery, however, more than 30 studies support the effectiveness of bariatric surgery in the treatment of type 2 diabetes.

Physician-initiated Alert Sparks Zimmer Investigation Of "Durom" Hip Failures

Zimmer is investigating failures of its Durom hip implants after a prominent joint reconstruction surgeon sent a letter reporting a series of problems with the device to the American Association of Hip and Knee Surgeons. [Preview]

Cardiologists Critique Consumer TV Advertising For Interventional Devices

Why are cardiologists arguing that direct-to-consumer television advertising of surgical devices raises more troubling questions than do many prominent pharmaceutical DTC ads? [Preview]

Medtronic Exec Will Bring Device Perspective To Clinical Trials Coalition

Full article reprinted from "The Gray Sheet," May 19, 2008

With a broad-based and seasoned executive board in place, the recently formed FDA/Duke University partnership aimed at improving clinical trials is gaining momentum and seeking to fill out its ranks.

On May 12, "The Gray Sheet" touched base with Clinical Trials Transformation Initiative (CTTI) executive board member Susan Alpert, chief quality and regulatory officer at Medtronic. Prior to overseeing all of Medtronic's quality, regulatory and clinical compliance efforts, Alpert held several positions at FDA in the centers for drugs and devices, including a six-year stint as the director of the Office of Device Evaluation.

The lone device industry rep on the group's executive board, Alpert said she will make it her priority to bring device-specific issues to the group's attention.