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Article: Drug-eluting stent safety triggers special FDA advisory panel.(News Wire)
- Article from:
- Healthcare Purchasing News
- Article date:
- October 1, 2006
CopyrightCOPYRIGHT 2006 Healthcare Purchasing News. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The FDA said it will hold a special meeting of a device advisory committee to assess new data about "small but significant" increases in the rates of death and myocardial infarction among patients treated with drug-eluting coronary stents. The agency said that its Circulatory System Devices Advisory Panel will meet before the end of the year to consider the implications of a meta-analysis reported in Spain and earlier data that suggested late-stenosis safety concerns with the devices. The agency added that it has already discussed safety concerns with the makers of the two FDA-approved drug-eluting stents-Cypher, a sirolimus-eluting stent sold by Cordis, a Johnson ...