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Perspective
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Volume 351:1593-1595 October 14, 2004 Number 16
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Problems with Drug-Eluting Coronary Stents — The FDA Perspective
Neal I. Muni, M.D., M.S.P.H., and Thomas P. Gross, M.D., M.P.H.

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The introduction of drug-eluting coronary stents in the United States has rapidly and profoundly affected the field of interventional cardiology. Met with widespread anticipation by the clinical community, drug-eluting stents are now used in a majority of intracoronary stenting procedures, justifying their characterization as a "transforming technology." However, both such stents that are currently approved by the Food and Drug Administration (FDA), the Cordis Cypher sirolimus-eluting stent and the Boston Scientific Taxus Express2 paclitaxel-eluting stent, have also been associated with highly publicized adverse events after they were approved for marketing, leading some to question their safety. As a by-product of . . . [Full Text of this Article]


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From the Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Md.


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