Endeavor PMA complete
This article was originally published in The Gray Sheet
Executive Summary
Medtronic submits the final module of its PMA application for the Endeavor zotarolimus-eluting stent Nov. 16. The application includes data from 4,100 patients with up to three years of follow-up. The completed submission comes as first-generation Cypher and Taxus drug-eluting stents are under increased scrutiny for late stent thrombosis. Medtronic will join Johnson & Johnson/Cordis, Boston Scientific and other drug-eluting stent makers in presenting thrombosis data before an FDA panel next month (1"The Gray Sheet" Oct. 30, 2006, p. 5)...