said Monday that a clinical trial of Endeavor IV met its primary endpoint.
The medical device company's investigational drug-eluting coronary stent was compared to
Taxus stent in a trial evaluating 1,548 patients at multiple centers in the U.S.
The Minneapolis-based company said it will hand over specific results to the Food and Drug Administration in support of the stent's premarket approval application and will present the final clinical data at the Transcatheter Cardiovascular Therapeutics conference in October.
"The Endeavor stent has produced excellent results across an extensive clinical program, with long-term clinical follow up extending to three and four years," said Scott Ward, president of Medtronic's CardioVascular unit. "The Endeavor stent will be reviewed by
the FDA at a panel this fall, and we continue to anticipate FDA approval later this calendar year."
Medtronic was recently higher by 85 cents, or 1.6%, at $53.71.