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Endeavor Zotarolimus-eluting stent approved for use in Canada

Medtronic : 27 March, 2008  (New Product)
Medtronic has received regulatory approval from Health Canada’s Therapeutic Products Directorate (TPD) for use of the Endeavor drug-eluting coronary stent (DES) system in the treatment of coronary artery disease.
Medtronic Canada expects to begin commercial sales of the Endeavor Stent in Canada by the end of March 2008.

Enabling a minimally-invasive alternative to open-heart bypass surgery, stents are tiny wire mesh tubes used to prop open coronary arteries that have been cleared of blockages to restore blood flow to the heart muscle. Approximately 90,000 stents are implanted in Canadian patients with coronary artery disease each year, according to research conducted by two of the leading Canadian cardiology societies. Drug-eluting stents deliver medication to the artery wall to reduce the chance that the artery will narrow again and require a repeat procedure.

“Endeavor represents a true next-generation drug-eluting Stent because of its design, which combines an advanced Stent platform with the potent drug zotarolimus and a biocompatible polymer,” said Dr Eric Cohen, director, Cardiac Catheterization Laboratory, Sunnybrook Health Sciences Centre, Toronto. “This device addresses an important need by demonstrating comparable clinical effectiveness to a first generation drug-eluting Stent while also exhibiting an excellent safety profile. In addition, it has the advantage of being highly flexible, which permits delivery through tortuous vessels of the coronary vasculature. Having this Stent available in Canada provides us with an important treatment option for Canadian patients.”

Cardiovascular disease accounts for the death of more Canadians than any other disease: Of the more than 70,000 Canadian deaths annually, 54 percent (approximately 38,000) are due to coronary artery disease, government statistics show.

“The approval of the Endeavor Stent in Canada is an important event for patients and physicians,” said Neil Fraser, vice president of Medtronic in Canada. “It brings an exciting new, next-generation technology to Canada, with a strong history of clinical results that show excellent efficacy and safety when used as directed. Combined with the outstanding deliverability that the Endeavor Stent provides, this news is most welcome in Canada.”

Extensive clinical research has shown that Endeavor provides a consistent and sustained reduction in the need for repeat procedures compared to a bare-metal stent, while also maintaining an excellent safety profile. The Endeavor clinical programme includes seven studies: three randomised controlled trials and four registries.

From this programme, Medtronic submitted data on more than 4,100 patients to Canada’s TPD for review, with follow-up out to as long as four years. This data encompasses one of the largest, most wide-ranging populations submitted to the TPD for a drug-eluting stent.

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.
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