Medtronic of Canada Ltd. 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. The company expects to begin commercial
sales of the Endeavor stent in Canada soon.
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 unique 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 program includes seven studies:
three randomized controlled trials and four registries. From this
program, 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. More
information is available online at http://www.EndeavorStent.com.
About Medtronic of Canada Ltd.
Medtronic of Canada has been headquartered in Mississauga, Ontario
since 1972. Medtronic of Canada sells, services and distributes
Medtronic products in Canada: medical devices used in cardiovascular
(including cardiac rhythm disease), diabetes, spinal and neurosurgery,
navigation, ear, nose and throat, and general surgery. Medtronic of
Canada employs more than 400 Canadians and has regional offices in
Vancouver and Montreal, as well as an education centre and a museum in
Mississauga.
About Medtronic
Medtronic, Inc., headquartered in Minneapolis, is a global leader
in medical technology,alleviating pain, restoring health, and extending
life for millions of people around the world.
For more information, visit http://www.medtronic.com or call
800/217-1617 ext. 5226 or 707/591-7367.
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