Medtronic gains FDA approval for Endeavor stent. Source: Medtronic.

The FDA today approved the first new drug-eluting stent (DES) since 2004, Medtronic's Endeavor zotarolimus-eluting coronary stent system to be used in the treatment of coronary artery disease.

Endeavor's FDA submission included the largest body of scientific studies ever submitted to FDA for a new drug-eluting stent, according to Medtronic. The ENDEAVOR clinical trial includes seven studies: three randomized controlled trials and four registries. The ENDEAVOR data submitted to the FDA in support of its DES included more than 4,100 patients, followed up for as long as four years.

This clinical research has shown that Endeavor provides a consistent and sustained reduction in the need for repeat procedures compared to a bare-metal stent, while also maintaining an excellent safety profile, according to the company. Endeavor has been associated with exceptionally low rates of stent thrombosis and no confirmed cases of very-late stent thrombosis.

In October 2007, a federal advisory panel of outside experts unanimously recommended that the FDA regulators approve Medtronic's Endeavor, contingent on follow-up safety studies.

Medtronic now enters the market formerly exclusive to the sirolimus-eluting Cypher stent from Johnson and Johnson's Cordis and the paclitaxel-eluting Taxus stent from Boston Scientific. Sales of Taxus and Cypher plunged about 30 percent last year because of concern over clots.

Also, Medtronic's entrance into the U.S. stent market surpassed Abbott Laboratories Xience stent, which was recommended for FDA approval by the Circulatory System Devices Advisory Panel in early December of 2007.

The Minneapolis-based Medtronic said that the U.S. market launch begins immediately.