The Food and Drug Administration gave marketing approval to Cordis Corp.'s drug-eluting stent, a tiny artery-opening device expected to transform the clinical and economic landscape of open-heart surgery. The so-called Cypher stent, with a list price of $3,195, releases an inflammation-fighting drug intended to reduce the frequency of artery reblockage following coronary angioplasty. The stent promises vastly improved outcomes but costs about three times as much as the bare metal stents now in use and also threatens to erode hospital volumes in coronary artery bypass surgery, typically a lucrative service line. Cordis, Miami Lakes, Fla., is a Johnson & Johnson company. Last August in an unprecedented action, the CMS jumped ahead of the FDA and announced it would provide incremental reimbursement for drug-eluting stents, over and above reimbursement for plain stents, once the device was approved. -- by Cinda Becker
To market, to market: FDA OKs drug-eluting stent
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