Most High-Risk Heart Devices Approved With No Tests

Jane Akre
November 25, 2012

Heart Valve rings

November 24, 2012 ~

Most readers of Mesh Medical Device News Desk are familiar with the ease with which surgical mesh and other medical devices make it to the market. An exchange of paperwork and a claim of 'substantial equivalence' to another device already being sold, and a manufacturer can launch his product- even a permanently implanted medical device - usually within months.

In this article in Clinical Cardiology, a comparison is made to cardiovascular device approvals in the U.S. A review of device approvals, published in the November 7, 2012 Journal of the American Medical Association (JAMA) by Dr. Connie E. Chen of Stanford Hospital notes that just over “40% of all high-risk cardiovascular devices reviewed by the FDA between 2000 and 2011 obtained premarket approval based on studies that included randomization to ‘active comparators.’ ”

Active comparators are devices already on the market (substantial equivalent) and can include implanted devices such as stents, implanted cardioverter-defibrillators, and left ventrical assist devices.

The authors write that 22% of devices approved by the FDA were based on studies with no form of control whatsoever. In other words, it was not compared to a conventional treatment. The remainder of approvals relied on controls from previous studies (13%), expert opinion, or performance goals (25%).

Co-author, Dr. Sanket S. Dhruva (U of California Davis), noted that about half of drugs had comparative data so researchers wanted to get a read on medical devices.

"We wondered what that [evidence base] looks like for devices," Dhruva explained. "Our feeling is that these high-risk devices are often permanently implanted and device removal can be treacherous. So the issue is, if you decide you are going to place a device, you want to make sure the indication is appropriate."

Dhruva adds, “We should really have a keen eye and make sure we know how these devices are going to affect our patients and what the risk-benefit ratio is in comparison to what is out there already.”

Dr. Dhruva states the FDA is underfunded and therefore is dependent on companies to assure safety.

Meanwhile the medical device industry is seeking faster FDA approvals in the future and consistently complains about the length of time it takes to get a device on the market, which for a device undergoing “substantial equivalent” approval is roughly two to four months at a cost of $4,000.

Dr. Chen worked with Dr. Rita Redberg (U of California, San Francisco) who has published extensively on medical devices.

Writing in the New England Journal of Medicine in January, Dr. Redberg notes that even as the Institute of Medicine called in 2011 for an overhaul of 510(k) approval process, the FDA has the ability currently to required post approval studies of medical devices and to initiate recalls, something the Government Accountability Office says is underused.

Learn More:

New England Journal of Medicine – Medical Devices – Balancing Regulation and innovation

Most high-risk CV devices approved without tests vs standard care

MDUFA for Another Five Years

FDA Folos Industry Lead to Shorten Time to Market

Data Raise Quesions on FDA Oversight, Chicago Tribune, May 21, 2011,0,922178.story

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