Problems with Drug-Eluting Coronary Stents — The FDA Perspective

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 . . .