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Canada approves Endeavor

This article was originally published in The Gray Sheet

Executive Summary

Health 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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Medtronic launches its Endeavor zotarolimus-eluting stent immediately upon FDA approval Feb. 1, and expects to ship 100,000 units to U.S. hospitals in the next 30 days. Endeavor is the first drug-eluting stent approved in nearly four years and the third DES on the U.S. market. Device industry analysts expect Endeavor to take 15%-20% of the near $2 billion U.S. DES market. As conditions of approval, Medtronic will conduct a 2,000-patient U.S. post-approval study, to be combined with data from 3,300 patients outside the U.S., as well as continue to follow patients in six Endeavor trials for five years. Abbott's Xience everolimus-eluting stent, also up for FDA approval this year, got a positive recommendation from an FDA advisory committee in November (1"The Gray Sheet" Dec. 3, 2007, p. 3)

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