26.03.2008 13:00:00
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Medtronic's New Endeavor(R) Zotarolimus-Eluting Stent Approved for Patients with Coronary Artery Disease in Canada
Medtronic of Canada Ltd. announced today that Medtronic, Inc.
(NYSE:MDT), 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 by the end of March.
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 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. (www.medtronic.com),
headquartered in Minneapolis, is the global leader in medical technology –
alleviating pain, restoring health, and extending life for millions of
people around the world.
Editor’s Note: Interviews with
physicians and Medtronic executives can be arranged by request.
Broadcast-quality video, including soundbites and animation, is
available through The News Market, www.thenewsmarket.com/medtronic,
and also via satellite, Pathfire and hard copy by contacting Dan
Schwartzberg at News Broadcast Network in New York: 212-684-8910, ext.
220; dschwartzberg@newsbroadcastnetwork.com. Any forward-looking statements are subject to risks and uncertainties
such as those described in Medtronic’s Annual
Report on Form 10-K for the year ended April 27, 2007. Actual results
may differ materially from anticipated results.
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