The introduction of drug-eluting coronary stents in the UnitedStates has rapidly and profoundly affected the field of interventionalcardiology. Met with widespread anticipation by the clinicalcommunity, drug-eluting stents are now used in a majority ofintracoronary stenting procedures, justifying their characterizationas a "transforming technology." However, both such stents thatare currently approved by the Food and Drug Administration (FDA),the Cordis Cypher sirolimus-eluting stent and the Boston ScientificTaxus Express2 paclitaxel-eluting stent, have also been associatedwith highly publicized adverse events after they were approvedfor marketing, leading some to question their safety. As a by-productof . . . [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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