Medtronic Endeavor Trial Meets Primary Endpoint

July 3, 2007

Medtronic announced a trial of its Endeavor stent met its primary, non-inferiority endpoint, showing the stent is comparable to Boston Scientific’s Taxus.

The ENDEAVOR IV Clinical Trial is a randomized, single-blind trial evaluating the safety and efficacy of the Endeavor drug-eluting stent as compared to the Taxus. The trial’s primary endpoint is target vessel failure — a composite of cardiac death, myocardial infarction and target vessel revascularization — at nine months. 

Medtronic said it will submit these data to the FDA to support its premarket approval application. An FDA panel will review the Endeavor this fall, according to the company.