Canada approves Endeavor
This article was originally published in The Gray Sheet
Executive SummaryHealth Canada's Therapeutic Products Directorate approves Medtronic's Endeavor zotarolimus-eluting coronary stent, the firm announces March 26. The approval was based on seven studies with a total of 4,100 patients followed up to four years. As a condition of approval, the company will submit to Health Canada annual updates on its 5,000-patient post-market trial, as well as other studies investigating the risk of stent thrombosis, myocardial infarction and optimal dual anti-platelet therapy. Medtronic launched Endeavor in Europe in 2005 and began U.S. marketing Feb. 1 following FDA approval (1"The Gray Sheet" Feb. 4, 2008, In Brief)
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