The Food and Drug Administration told doctors it doesn't appear that the new drug-eluting stent is responsible for more clotting in patients than traditional stents. The FDA notified doctors in October of reports of clotting and possible hypersensitivity reactions 30 days after implantation of the artery-opening device and asked patients and doctors to report similar incidents. As of Nov. 21, there have been more than 360 cases of clotting and more than 70 deaths reported, the FDA said. Hypersensitivity reactions in most cases were minor, the agency said. Cordis Corp., a Johnson & Johnson company that makes the stent, is conducting a post-approval study and expects to have results for the FDA in early 2004. The FDA emphasized that it considers the Cordis stent safe and effective when used according to labeling and said that hundreds of thousands of patients have benefited from the stent since it was approved by the FDA in April. -- by Cinda Becker
FDA: Clotting rates same for new and old stents
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