Medtronic Announces First Patient Enrollment in ENDEAVOR IV

Medtronic has begun enrollment in its ENDEAVOR IV clinical trial, the final phase of its ENDEAVOR clinical program to be used in support of U.S. premarket approval.

The ENDEAVOR IV clinical trial is a randomized, single-blind trial evaluating the safety and efficacy of the Endeavor drug-eluting coronary stent as compared to the Taxus paclitaxel-eluting coronary stent system from Boston Scientific. The ENDEAVOR IV study will include approximately 1,548 patients randomized one-to-one against the Taxus stent and will be performed at approximately 80 centers in the U.S. and Canada.

The primary endpoint of the trial is target vessel failure at nine months, with a secondary endpoint of major adverse cardiac events at 30 days. The trial includes angiographic and intravascular ultrasound follow-up at eight months for a subset of 328 patients.