In the light of recent studies suggesting that drug-elutingstents may pose a risk of thrombosis that was not observed duringpre-market testing, the Food and Drug Administration (FDA) conveneda meeting of its Circulatory System Devices Advisory Panel onDecember 7 and 8, 2006, to examine the safety of these devices.The FDA will carefully consider the information and views presentedat the meeting in deciding on future actions.
An understanding of the mechanisms of neointimal growth withinbare-metal stents led to the development of drug-eluting stentsdesigned to reduce restenosis rates. Both drug-eluting stentsapproved by the FDA . . . [Full Text of this Article]
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Dr. Farb is a medical officer, and Ms. Boam the chief of the Interventional Cardiology Devices Branch, of the Office of Device Evaluation, Center for Devices and Radiological Health, FDA, Rockville, MD.
A discussion between Dr. Donald Baim, chief medical and scientific officer of Boston Scientific, and Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, on the risks and benefits of drug-eluting stents can be heard at www.nejm.org.
This article (10.1056/NEJMp068304) was published at www.nejm.org on February 12, 2007.
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