Most High-Risk CV Devices Approved Without Tests Vice Standard Care: American Medical Association

Published: Nov 30, 2012

"Comparative effectiveness" has become a buzzword in medical research as well as healthcare policy, yet a recent review of cardiovascular device approvals in the US suggests only a minority are ever tested against standard treatment before they are approved for the US market [1]. Writing in a research letter published November 7, 2012 in the Journal of the American Medical Association, Dr Connie E Chen (Stanford Hospital, Palo Alto, CA) and colleagues note that just 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." The devices they reviewed included stents, implantable cardioverter defibrillators, and left ventricular assist devices; "active comparator" was defined as proven interventions already used by American physicians at the time the device was being tested. The rest of the studies that formed the basis for device approvals over this period used historical controls from previously conducted studies (13%) or so-called "objective performance criteria" or "performance goals" (25%)—typically numerical benchmarks established by published studies of similar devices or, in some cases, expert opinion alone. A full 22% of devices obtained FDA approval on the basis of studies with no form of control whatsoever. "It's hard to know if a new device is safe and more effective than alternative treatments unless it is compared with conventional treatment," Chen and colleagues write. "While occasionally use of active controls may not be possible . . . more frequent use of a comparator group may help to better inform clinical and regulatory decisions."

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