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news.Medtronic has received regulatory approval from the Health Canada's Therapeutic Products Directorate for use of the Endeavor drug-eluting coronary stent system in the treatment of coronary artery disease.
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The company expects to begin commercial sales of the Endeavor stent in Canada by the end of March, 2008. Medtronic will also provide annual updates on its Endeavor post-market clinical registries and trials for a period of five years as a condition of Health Canada’s approval.
This will include results under the proposed single-arm post-approval study involving at least 5,000 patients that Medtronic will be conducting, as well as updates on studies and trials with respect to late stent thrombosis, myocardial infarction, death and optimal dual antiplatelet therapy.
Eric Cohen, director, Cardiac Catheterization Laboratory, Sunnybrook Health Sciences Centre, Toronto, said: “Endeavor represents a true next-generation drug-eluting stent because of its unique design, which combines an advanced stent platform with the potent drug zotarolimus and a biocompatible polymer.”