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Medtronic Updates Long-Term ENDEAVOR I-II Clinical Data Showing,Sustained Safety and Significant Reductions in Repeat Procedures

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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