(25-01-13) Skimpy Evidence Supports FDA Approval of Devices

More than half of the high-risk cardiovascular devices approved in the past decade had no supporting active control data.
The FDA approval process is not as stringent for devices as it is for drugs. To assess the quantity and quality of evidence that informs approval of high-risk cardiovascular devices, investigators examined FDA summaries of safety and effectiveness data for all such devices approved from 2000 through 2011.
In 121 device summaries, 203 supporting clinical studies were cited. Comparators for the 353 primary endpoints were as follows:
? Active control, 40%
? Historical control, 13%
? Objective performance criteria or goal, 26%
? No control, 22%
Approval of only 48% of devices was based on at least one primary endpoint with an active control, and 35% of devices were approved without any control data (see table).
Comment: This study sends an important message to the medical community. Many devices are being approved based on remarkably weak clinical research data ? and comparative effectiveness studies using active controls are uncommon. Without such information, we cannot make truly informed choices between different options.
? Harlan M. Krumholz, MD, SM
To join a discussion with Rita F. Redberg, MD, MSc, one of the authors of this study, read her blog on CardioExchange, an online community hosted by the New England Journal of Medicine and Journal Watch and dedicated to improving cardiac patient care. Membership is free for medical professionals.

Source:
Published in Journal Watch Cardiology November 28, 2012

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