Medtronic DES trial
This article was originally published in The Gray Sheet
Executive Summary
Firm announces Oct. 19 an 8,000-patient, 200-site clinical trial assessing and comparing safety measures of its Endeavor zotarolimus-eluting stent and Johnson & Johnson's Cypher sirolimus-eluting stent. The primary endpoint for the PROTECT study will be overall stent thrombosis, and it will evaluate use of the stents in a "real world" population. Drug-eluting stents have come under fire in recent months due to concerns that thrombosis rates in clinical practice exceed levels seen in the products' pivotal trials (1see related story, p. 3). Endeavor, available in Europe and other international markets since 2005, is on track for FDA approval in 2007...