As suggested by Johnson & Johnson's purchase of Conor Medsystems, the major players are lining up for battle in the "second-generation" drug-eluting stent (DES) wars. Another indication is the report last month by Medtronic (Minneapolis) that it has filed the fourth and final module of its premarket approval (PMA) application to the FDA for its Endeavor DES. Medtronic's PMA submission includes safety and efficacy data on about 4,100 patients treated with Endeavor that include follow-up for as long as three years — a total of 27,000 pages, the company says.
Medtronic said the Endeavor PMA "sets a new standard for clinical data submitted to the FDA … from the most wide-ranging patient population and for patients with the longest follow-up ever submitted to support the safety and efficacy" of DES.
"We've submitted an extremely robust dossier on the Endeavor drug-eluting stent, and we look forward to working with the FDA on an expeditious PMA review," said Scott Ward, president of the vascular business at Medtronic. He said Endeavor's "polymer-drug combination [is] specifically designed to reduce restenosis while maintaining a favorable safety profile. We have submitted a PMA that strongly supports the safety and efficacy criteria needed for U.S. approval."
The Endeavor is CE-marked and commercially available in more than 100 countries.
It is made of a cobalt alloy with a modular architecture designed to enhance deliverability. In addition to being coated with the cytostatic drug, zotarolimus, Endeavor is coated with phosphorylcholine (PC Coating), a biocompatible polymer designed, Medtronic says, "to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, leading to an optimal healing response around the stent following implantation."