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Findings suggest cardiovascular devices often approved by FDA without high-quality studies

Published in Drug Week, January 15th, 2010

Pre-market approval by the FDA of cardiovascular devices is often based on studies that lack adequate strength or may have been prone to bias, according to a study in the December 23/30 issue of JAMA. 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...

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Source: Drug Week (2010-01-15)

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