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Perspective
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Volume 356:984-987 March 8, 2007 Number 10
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Stent Thrombosis Redux — The FDA Perspective
Andrew Farb, M.D., and Ashley B. Boam, M.S.

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-PubMed Citation
In the light of recent studies suggesting that drug-eluting stents may pose a risk of thrombosis that was not observed during pre-market testing, the Food and Drug Administration (FDA) convened a meeting of its Circulatory System Devices Advisory Panel on December 7 and 8, 2006, to examine the safety of these devices. The FDA will carefully consider the information and views presented at the meeting in deciding on future actions.

An understanding of the mechanisms of neointimal growth within bare-metal stents led to the development of drug-eluting stents designed to reduce restenosis rates. Both drug-eluting stents approved 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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