12.06.2006 13:00:00
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Medtronic Announces Reimbursement Approval in France for the Endeavor(R) Drug-Eluting Coronary Stent System
"We are very pleased that the Endeavor drug-eluting coronary stentwill now be fully available for patients and physicians in France,"said Patrick Mackin, vice president of Medtronic's vascular businessin Western Europe. "The Endeavor stent system provides an excellentcombination of deliverability, effectiveness and safety, withlong-term clinical results that clearly show it to be an ideal choicefor physicians considering a drug-eluting stent for their patients."
Last month, Medtronic presented data at the Paris Course onRevascularization that provided compelling clinical evidencedemonstrating the long-term safety and efficacy of the Endeavor stent.Three-year and two-year results from the ENDEAVOR I and ENDEAVOR IIclinical trials demonstrated low rates of repeat procedures, TargetLesion Revascularization, as well as low rates of major adverseclinical events (MACE) such as death and myocardial infarction. Inaddition, there was no late stent thrombosis reported in either of thetwo trials. Late stent thrombosis is the formation of dangerous bloodclots that potentially can lead to heart attacks or death. In all ofits Endeavor clinical trials to date, there have been no reportedcases of late stent thrombosis in more than 1,300 patients who havebeen followed for at least one year.
"The clinical data for the Endeavor stent is strong, withlong-term safety and efficacy results that make it a welcome additionto the drug-eluting stent market in France," said Dr. Jean Fajadet,Clinique Pasteur Unite de Cardiologie Interventionnelle, Toulouse,France, and a co-principal investigator of the ENDEAVOR II trial. "Thesafety record is very impressive, with no late stent thrombosis.Almost 90 percent of the patients who received an Endeavor stent areMACE free and almost 94 percent of the patients required no furthertreatment or revascularization. It is clear that the Endeavor systemis performing well for patients who need vascular intervention."
With reimbursement approval in France, the Endeavor drug-elutingcoronary stent is now available in all Western European markets.Nearly one-third of all deaths in France are attributed tocardiovascular disease, and approximately 165,000 stents are used inFrance each year. About 55 percent of these are drug-coated stents.
The Endeavor stent is not yet available in the United States.However Medtronic filed its first Pre-Market Approval module with theU.S. Food and Drug Administration last October and the company expectsFDA approval in mid-2007. The Endeavor stent has been commerciallyavailable in most of Europe and in many other international marketssince August 2005.
Made of a cobalt alloy, the Endeavor stent has a unique modulararchitecture designed to enhance deliverability. In addition to thedrug compound zotarolimus (ABT-578), Endeavor is coated withphosphorylcholine, a polymer designed to simulate the outside surfaceof a red blood cell and mimic the structure of the natural cellmembrane, leading to an ideal healing response.
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 theworld.
Caution: In the United States, the Endeavor drug-eluting CoronaryStent is an investigational device with an investigational drug(zotarolimus, ABT-578) and exclusively for clinical investigation.
Any forward-looking statements are subject to risks anduncertainties such as those described in Medtronic's Quarterly Reporton Form 10-Q for the quarter ended January 27, 2006. Actual resultsmay differ materially from anticipated results.
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