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Article: Panel deems drug-eluting stents safe for on-label use, but wants more data.(Regulatory Report)
- Article from:
- Medical Design Technology
- Article date:
- January 1, 2007
CopyrightCOPYRIGHT 2007 Advantage Business Media. 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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FDA advisory panel members decided Dec. 7 that the benefit of drug-eluting stent use in FDA-approved indications outweighs the risks. But the panel expressed some skepticism about the strength of data measuring the long-term incidence of blood clots.
"A very wise and large advisory committee was able to look at all the data today in great detail and conclude that ... the two FDA-approved drug-eluting stents, when used for on-label indications, are reasonably sate and effective," Bram Zuckerman, director of CDRH's cardiovascular device review division, told
The Gray Sheet.
The Circulatory System Devices Panel met Dec. 7-8 to assess the risk of ...