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

to 20.7% for Driver (p= less than 0.001), while the combined cardiac death/myocardial infarction (MI) rate for Endeavor was 4.5% and 6.7% for Driver (p=0.125). When compared to Driver, Endeavor has fewer total deaths, fewer cardiac deaths and fewer MIs at three years.

"These are well-conceived and well-managed clinical trials. The results are excellent and the clinical investigators have achieved a very admirable level of patient follow-up," said Jean Fajadet, M.D., Clinique Pasteur Unite de Cardiologie Interventionnelle, Toulouse, France, and one of the principal investigators for the ENDEAVOR II trial. "The number of repeat procedures is low, there are few adverse cardiac events and the lack of late stent thrombosis is truly extraordinary."

Using pre-specified, protocol-defined data adjudicated by the Harvard Clinical Research Institute, there have been no instances of late or very late stent thrombosis among more than 1,300 patients receiving the Endeavor stent. During the late-breaking session, Dr. Zeiher also presented Endeavor data using the broader Academic Research Consortium (ARC) definitions of stent thrombosis. Under the definitions for definite and probable stent thrombosis, Endeavor's cumulative rate in the ENDEAVOR I-III trials is 0.5% at three years and the Driver bare metal stent has a rate of 1.5%. Additionally, composite analysis of myocardial infarction and cardiac mortality showed three-year freedom from death or MI of 96.0% for Endeavor and 93.4% for the Driver bare metal stent.

"The body of data now available on Endeavor is significant and the results are impressive," said Scott Ward, senior vice president of the CardioVascular business at Medtronic. "We have made several major presentations of Endeavor data during the last year, with consistent and predictable results. Using either the pre-specified protocol definition or the new ARC definitions, these data demonstrate that Endeavor is highly effective at preventing repea
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