BARCELONA, Spain--(BUSINESS WIRE)--May 22, 2007 - Medtronic
(NYSE:MDT) today presented new long-term data from the ENDEAVOR
clinical trial program reinforcing the existing safety and efficacy
profile of the Endeavor(R) drug-eluting coronary stent system.
Four-year results from the 100-patient first-in-man ENDEAVOR I
trial and three-year results from the nearly 1,200 patient ENDEAVOR
II trial demonstrate that Endeavor is associated with sustained
safety, significant reductions in repeat procedures and no late
stent thrombosis in either trial using the pre-specified trial
protocol definitions. The ENDEAVOR II study also showed that the
Medtronic Driver(R) bare metal stent offers consistent and durable
long-term clinical results.
The data was presented by Andreas Zeiher, M.D., J.W.
Goethe-University, Frankfurt, Germany, during the EuroPCR's
late-breaking clinical trial session. The Endeavor stent is
approved in more than 100 countries worldwide and currently is
under review by the U.S. Food and Drug Administration. FDA approval
is anticipated in the second half of 2007.
The ENDEAVOR I data continue to show excellent long-term
results, with only one clinical event between years three and four,
a non-cardiac death from cancer. Target Lesion Revascularization
(TLR) at four years was 3.1% and Target Vessel Revascularization
(TVR) was 5.2%. The Major Adverse Cardiac Event (MACE) rate, one of
the trial's primary endpoints, was 7.2%, with no late stent
thrombosis events in this patient cohort.
Through three years of follow-up in the ENDEAVOR II trial, the
TLR rate was 7.3%, compared to 14.7% for the Driver bare metal
control arm (p= less than 0.001), representing a 50% reduction in
the need for repeat procedures. Target Vessel Failure, the trial's
primary endpoint, was 12.8% for Endeavor and 21.4% for Driver, a
40% reduction (p= less than 0.001). Endeavor showed a MACE rate of
12.0% at three years, compared
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