FDA News

FDA Advisory Panel to Review Medtronic’s Endeavor Drug Eluting Stent

(Aug 21, 2007)-- Medtronic announced it has been informed by the U.S. Food and Drug Administration (FDA) that an Advisory Panel will review the Premarket Approval (PMA) application for the Endeavor® Drug Eluting Coronary Stent in October. The FDA will announce the date and the complete agenda four to six weeks prior to the meeting in accordance with their normal communications regarding public panel meetings.

Medtronic’s PMA submission includes safety and efficacy data on more than 4,100 patients who have been treated with Endeavor in clinical trials that include follow up for as long as four years. The Endeavor PMA sets a new standard for clinical data submitted to the FDA, with data from the largest, most wide-ranging patient population and for patients with the longest follow-up ever submitted to support the safety and efficacy of a new drug-eluting stent (DES).

“Endeavor represents a new generation of drug-eluting stents, with a polymer-drug combination specifically designed to reduce restenosis while maintaining a favorable safety profile,” said Scott Ward, president of the CardioVascular business at Medtronic. “We have submitted a PMA that strongly supports the safety and efficacy criteria needed for approval in the United States, and we continue to anticipate approval later this calendar year.”

Patient follow-up in the Endeavor clinical trials has been extensive. The number of patients included in the Endeavor PMA is nearly double the number of the two commercially available drug-eluting stents combined at the time of their submission. The Endeavor PMA includes safety and efficacy data from the following major clinical trials or registries:

* the ENDEAVOR I first-in-man study
* the ENDEAVOR II randomized, controlled trial comparing the performance of the Endeavor drug-eluting stent to the Medtronic Driver bare metal stent
* the ENDEAVOR II Continued Access study
* the ENDEAVOR III and ENDEAVOR IV randomized, controlled trials comparing Endeavor against both of the DES products commercially available in the United States
* the E-Five post-market registry conducted outside the United States

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