Medtronic completes enrollment of trial for Endeavor coronary stent

New York, June 27 - Medtronic, Inc. said it completed patient enrollment in its Endeavor IV clinical study of Endeavor drug-eluting coronary stent system.

The Minneapolis medical device maker also said it completed enrollment in the Resolute study evaluating its next-generation drug-eluting coronary stent product and the Endeavor-Japan study evaluating the Endeavor stent at 12 clinical sites in Japan.

"Completion of patient enrollment in these three trials is a tremendous achievement for the Endeavor clinical program," said Scott Ward, president of Medtronic's vascular business, in a news release.

"Along with the data from our previous Endeavor trials, the results of the Endeavor IV study will provide a very comprehensive picture of Endeavor's clinical performance. Never before has a drug-eluting stent been subjected to such a rigorous examination prior to approval. We look forward to the results of Endeavor IV and continuing with a regulatory pathway that will bring the Endeavor stent to market in the United States."

Along with the Endeavor I, II and III trials, the IV study will provide safety and efficacy data on more than 2,000 patients who have had the Endeavor stent implanted over the past 42 months. This data will be used to support Medtronic's Pre-Market Approval submission to the Food and Drug Administration.

Endeavor IV is evaluating 1,548 patients at 80 clinical centers in the United States, with a primary endpoint of target vessel failure at nine months and a secondary endpoint of major adverse cardiac events at 30 days.

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