March 30,
2009-- Minneapolis -- Medtronic, Inc. (NYSE: MDT),
today announced approval of its Endeavor drug-eluting coronary
stent system by the Japanese Ministry of Health, Labor and
Welfare (MHLW), clearing the way for the highly anticipated
launch of the product in the world’s second largest market
for advanced medical technology. Medtronic plans to launch
the Endeavor drug-eluting stent (DES) immediately following
the authorization of reimbursement which is expected on May
1.
Following the launch in Japan, the Endeavor DES will be commercially available
for the treatment of coronary artery disease in every major market in the world. The
Endeavor DES provides the reassurance of long-term safety and durable efficacy
in the treatment of coronary artery disease.
“The large and growing body of evidence from clinical studies and clinical practice
around the world continues to demonstrate the enduring benefits of the Endeavor
stent for patients with coronary artery disease,” said Sean Salmon, vice president
of Medtronic CardioVascular and general manager of Medtronic’s Coronary and Peripheral
business. “We look forward to bringing these benefits to Japan very soon.”
The robust ENDEAVOR clinical program has demonstrated that the Endeavor DES is
associated with exceptionally low rates of stent thrombosis, myocardial infarction
(MI) and cardiac death, as well as low rates of clinically-driven target lesion
revascularization (TLR), out to as long as five years of patient follow-up. Representing
various world geographies (including Japan) and patient subsets, the program
has enrolled more than 10,000 subjects to date and will ultimately enroll more
than 20,000 subjects in a combination of randomized controlled and single-arm
trials.
ENDEAVOR Japan (n=99), a single-arm trial of Japanese subjects with a primary
endpoint of TVF at nine months, reflects the consistent results of the ENDEAVOR
clinical program overall and contributed to the regulatory approval of the Endeavor
DES in Japan. At two years, the TVF rate in ENDEAVOR Japan was 8.7 percent, comparable
to the same measure in other trials of the Endeavor DES, and there have been
no instances of definite/probable stent thrombosis (early, late or very late),
with predictably low rates of death (2.2 percent) and MI (2.2 percent).
The Endeavor DES received the CE (Conformité Européene) mark in August 2005 and
was approved by the U.S. Food and Drug Administration (FDA) in February 2008.
It is part of Medtronic’s broad coronary stents portfolio, which provides physicians
with choices to address the spectrum of clinical needs. 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. 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 25, 2008. Actual results
may differ materially from anticipated results.
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