Studies Question FDA Approvals of Cardiac Devices

The New York Times reports that two studies have “found shortcomings in some clinical trials accepted by the FDA over the last decade in connection with the approval of high-risk cardiovascular devices,” such as “pacemakers, implanted defibrillators, and…coronary stents.” For its part, the FDA said it “is developing guidelines that will set tougher scientific standards for data from tests on humans” that medical device makers submit.

The first study, published in the December issue of the Journal of the American Medical Association (JAMA), showed that many cardiovascular devices are not subjected to rigorous safety and effectiveness research before being approved for use and that “it’s common for such devices to receive…approval based on information from only a single study, which raises questions about the quality of data on which some cardiovascular device approvals are based.”

Meanwhile, a second study appearing in the American Journal of Therapeutics, co-authored by a medical reviewer from the FDA’s cardiovascular device division, found that studies submitted for approval of cardiovascular devices often lack important information, including details on the studies’ participants.  The Associated Press reports that the second study “found about 40 percent of pivotal studies lacked precise targets for how safety would be measured,” and researchers “failed to fully account for what happened to all patients enrolled in the research.”


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