Medtronic begins Endeavor IV trial

Medical device developer Medtronic said that enrollment has begun in its Endeavor IV clinical trial, the final phase of its Endeavor clinical program to be used in support of a Food and Drug Administration premarket approval (PMA) application.

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 Natick, MA-based Boston Scientific, according to Minneapolis-based Medtronic.

The 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, Medtronic said. The primary end point of the trial is target-vessel failure at nine months, with a secondary end point 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, the company said.

By staff writers
April 13, 2005

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