The U.S. Food and Drug Administration (FDA) has recommended for clearance Medtronic's Endeavor drug-eluting stent for treatment of coronary artery disease, the company reported.
The FDA's Circulatory System Devices Panel voted to recommend that the product's labeling reflect the clinical trial protocol use of dual anti-platelet therapy and the available professional guidelines on its use, as well as a postmarket single-arm registry of at least 5,000 patients followed for a minimum of five years.
Endeavor is available in more than 100 countries, Minneapolis-based Medtronic said; it remains an investigational device in the U.S.
By AuntMinnie.com staff writers
October 11, 2007
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