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Cardiovascular Devices Often Approved by FDA Without High-quality Studies, Study Says
The researchers found that of nearly 80 high-risk devices, the majority received approval based on data from a single study.
Cardiovascular devices are increasing in number and usage. "In 2008, at least 350,000 pacemakers, 140,000 implantable cardioverter-defibrillators, and 1,230,000 stents were implanted. Although there has been recent scrutiny of evidence used in the U.S. Food and Drug Administration (FDA) drug approval process, less attention has been paid to the approval process for medical devices," the authors write. They add that the study data on which FDA approval is based should be of high quality. "Ideally, this evidence should consist of randomized, double-blinded studies with adequate controls, sufficient duration, and thorough follow-up on prespecified primary end points without bias."
Sanket S. Dhruva, M.D., of the University of California, San Francisco, and colleagues analyzed the type and quality of study evidence used by the FDA for the premarket approval (PMA) of cardiovascular devices. These types of devices were included in the study because it was expected they would undergo the most stringent approval process, given their increasing usage and potential impact on illness and risk of death. The authors conducted a systematic review of 123 summaries of safety and effectiveness data (SSEDs) for 78 PMAs for high-risk cardiovascular devices that received PMA between January 2000 and December 2007, examining the methodological characteristics and primary end points. SSEDs are intended to present a reasoned, objective, and balanced critique of the scientific evidence which served as the basis of the decision to approve or deny the PMA.
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