Medtronic’s Endeavor Drug-Eluting Coronary Stent System

Medtronic, Inc. announced that it has submitted the final modules of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration for the Endeavor® drug-eluting coronary stent system. Medtronic’s PMA submission includes safety and efficacy data on approximately 4,100 patients who have been treated with Endeavor in clinical trials that include follow up for as long as three 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).

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

The Endeavor stent, which received CE Mark in 2005 and is currently commercially available in more than 100 countries worldwide, is made of a cobalt alloy with a unique modular architecture designed to enhance deliverability. In addition to the potent cytostatic drug, zotarolimus, Endeavor is coated with phosphorylcholine (PC Coating), a biocompatible polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, leading to an optimal healing response around the stent following implantation.