Endeavor Drug-Eluting
Stent Is First to Receive CE Mark for Treating Acute Coronary
Syndrome
European Clearance Includes Unstable Angina and Acute Heart Attack
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Medtronic
Endeavor Stent |
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May 19, 2009 -- Barcelona --
Medtronic, Inc. (NYSE: MDT), today announced that its Endeavor
drug-eluting stent (DES) is the first and only coronary stent
to have received CE (Conformité Européene) Mark approval for
treating patients with acute coronary syndrome (ACS), which includes
unstable angina and acute myocardial infarction (AMI), commonly
known as heart attack. |
Medtronic is launching the unique ACS indication for the Endeavor
DES today at PCR, a large and prestigious international meeting of
interventional cardiologists. At this meeting today, Prof. Martin
Rothman of the London Chest Hospital in the U.K. released positive
new 12-month data from the international real-world registry E-Five
study (n=8,314) that show comparable outcomes for Endeavor DES patients
with and without ACS .
“Considering the distinctive safety record of the Endeavor
stent, this indication for ACS makes perfect sense,” said Prof.
Rothman. “Results from the E-Five study support the use of
the Endeavor stent in real-world clinical practice, including ACS
patients.”
Clinical research shows that ACS patients are at higher risk of
stent thrombosis and mortality than non-ACS patients. ACS is a complex
disease state for which drug-eluting stents are sometimes avoided
due to concerns over long-term safety and patient compliance with
antiplatelet medication.
“Of critical importance for safety, the biocompatibility of
the Endeavor stent allows rapid and complete healing of the vessel
wall,” explained Sean Salmon, vice president and general manager
of Medtronic CardioVascular’s Coronary and Peripheral business. “We
believe that this healthy healing is the key to long-term safety
and efficacy.”
The E-Five study demonstrated no statistically
significant difference on the primary endpoint – the rate of major adverse cardiac
events (MACE) at one year – between ACS patients (7.8 percent,
n=3,973) and non-ACS patients (7.2 percent, n=4,341). Rates of death,
MI and late stent thrombosis (LST) at one year were similarly low
and comparable between the two groups.
- All-cause mortality – 2.7% ACS,
2.2%, non-ACS
- Cardiac death – 2.0% ACS, 1.5%
non-ACS
- MI – 1.8% ACS, 1.5% non-ACS
- Cardiac death + MI – 3.4% ACS,
2.7% non-ACS
- LST (ARC def/prob) – 0.5% ACS,
0.3% non-ACS
Low and similar rates of standard efficacy measures were also observed,
including target lesion revascularization (TLR), target vessel revascularization
(TVR) and target vessel failure (TVF). On all these measures, there
were no statistically significant differences between the ACS and
non-ACS groups.
Medtronic’s Endeavor stent originally
received the CE mark in August 2005 as a treatment for coronary
artery disease. This latest
approval enables Medtronic to market the Endeavor DES specifically
for ACS patients in the European Union, and all other countries that
recognize the CE Mark. These countries do not include the United
States or Japan, where the Endeavor DES is also commercially available
but is not indicated for ACS patients.
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.
Source: Medtronic,
Inc.
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