A Food and Drug Administration (FDA) expert panel has spoken on the issue of drug-eluting stent (DES) safety, and while a lot of people were listening, the experts, in the end, could not come up with much of anything new to say, to the relief of many industry participants. A panel of FDA advisors, headed by William Maisel, MD, of Beth Israel Deaconess Medical Center (Boston, MA), convened for two days in early December to consider DES safety, particularly the risk of late-stent thrombosis, which emerged as a significant concern at recent cardiology meetings (refer to Medtech Insight, October 2006, p. 307 and November/December 2006, p. 354).
The panel heard from representatives of the two current U.S. DES suppliers, Boston Scientific Corp.(Natick, MA) and Cordis Corp. /Johnson & Johnson (Miami Lakes, FL), both of which presented a...
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