FDA Panel to Review Medtronic’s Endeavor Stent

Medtronic announced that an FDA advisory panel will review its premarket approval application for the Endeavor drug-eluting stent in October.

The submission includes safety and efficacy data on more than 4,100 patients treated with Endeavor in clinical trials that include follow-up for as long as four years, Medtronic said. The Endeavor application “sets a new standard” for clinical data submitted to the FDA, with data from the largest, most wide-ranging patient population and for patients with the longest follow-up ever submitted to support the safety and efficacy of a new drug-eluting stent, the company added.

“Endeavor represents a new generation of drug-eluting stents, with a polymer-drug combination specifically designed to reduce restenosis while maintaining a favorable safety profile,” Scott Ward, president of the CardioVascular business at Medtronic, said. 

Medtronic said it anticipates approval of the stent later this year.