Chairman Requests Information on Drug-Eluting Cardiac Stents
Henry A. Waxman (D-California), Chairman of the Committee on Oversight and Government Reform, requested documentation from Boston Scientific and Cordis Corporation on drug-eluting cardiac stents available from each device manufacturer on February 28th. Safety and off-label use of these stents are part of an ongoing Congressional inquiry about medical device research and marketing strategies.
An FDA investigation into eluting cardiac stents resulted in a panel meeting in December 2006. This meeting raised concerns about device safety. Findings reported in the Journal of the American Medical Association (JAMA) suggested that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis. Internal data from Boston Scientific revealed a higher rate of clotting in patients (ppt slideshow) with the drug-eluting cardiac stents compared to older stents manufactured with bare metal.
Waxman is requesting extensive information from the device manufacturers, including studies and reports used for FDA approval and labeling as well as all marketing materials. Both companies agreed to comply with the request to furnish materials by March 21st.
Related stories:
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- Drug-Coated Stents Not Always Best Option
- FDA Overhauls Medical Device Review Process
- Heart Bypass Surgery Gets a Second Look
March 6, 2007 Related topics: Legal & legislative, Quality, Safety, Errors