After recognizing coronary drug-eluting stents as a "breakthroughtechnology" and granting them expedited review status, the Foodand Drug Administration (FDA) approved two such devices foruse in 2003 (Cordis's sirolimus-eluting Cypher stent) and 2004(Boston Scientific's paclitaxel-eluting Taxus stent). Cardiologistsquickly embraced the new technology; by the end of 2004, drug-elutingstents were used in nearly 80% of percutaneous coronary interventionsin the United States, and within 3 years, several million drug-elutingstents had been implanted worldwide. Recently, however, concernsabout an increased risk of late stent thrombosis have arisenand have been exacerbated by insufficient and conflicting information. . . [Full Text of this Article]
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Dr. Maisel is a cardiologist at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School — both in Boston. Dr. Maisel is also chair of the FDA Circulatory System Devices Advisory Panel.
This article (10.1056/NEJMp068305) was published at www.nejm.org on February 12, 2007.
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