Healthcare Industry News: drug-eluting stent
News Release - June 12, 2006
Medtronic Announces Reimbursement Approval in France for the Endeavor(R) Drug-Eluting Coronary Stent SystemMINNEAPOLIS--(HSMN NewsFeed)--June 12, 2006--Medtronic, Inc. (NYSE:MDT ) today announced that it has received reimbursement approval in France for the Endeavor® drug-eluting coronary stent (DES) system. The announcement was made following publication in the official French government journal, "Journal Officiel de la Republique Francaise," on June 8, 2006. The company said the stent will be available June 21 to public and private hospitals throughout France, providing physicians and patients with a clinically-proven option for the treatment of coronary artery disease in one of the largest DES markets in Europe.
"We are very pleased that the Endeavor drug-eluting coronary stent will now be fully available for patients and physicians in France," said Patrick Mackin, vice president of Medtronic's vascular business in Western Europe. "The Endeavor stent system provides an excellent combination of deliverability, effectiveness and safety, with long-term clinical results that clearly show it to be an ideal choice for physicians considering a drug-eluting stent for their patients."
Last month, Medtronic presented data at the Paris Course on Revascularization that provided compelling clinical evidence demonstrating the long-term safety and efficacy of the Endeavor stent. Three-year and two-year results from the ENDEAVOR I and ENDEAVOR II clinical trials demonstrated low rates of repeat procedures, Target Lesion Revascularization, as well as low rates of major adverse clinical events (MACE) such as death and myocardial infarction. In addition, there was no late stent thrombosis reported in either of the two trials. Late stent thrombosis is the formation of dangerous blood clots that potentially can lead to heart attacks or death. In all of its Endeavor clinical trials to date, there have been no reported cases of late stent thrombosis in more than 1,300 patients who have been followed for at least one year.
"The clinical data for the Endeavor stent is strong, with long-term safety and efficacy results that make it a welcome addition to 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. "The safety record is very impressive, with no late stent thrombosis. Almost 90 percent of the patients who received an Endeavor stent are MACE free and almost 94 percent of the patients required no further treatment or revascularization. It is clear that the Endeavor system is performing well for patients who need vascular intervention."
With reimbursement approval in France, the Endeavor drug-eluting coronary stent is now available in all Western European markets. Nearly one-third of all deaths in France are attributed to cardiovascular disease, and approximately 165,000 stents are used in France 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 the U.S. Food and Drug Administration last October and the company expects FDA approval in mid-2007. The Endeavor stent has been commercially available in most of Europe and in many other international markets since August 2005.
Made of a cobalt alloy, the Endeavor stent has a unique modular architecture designed to enhance deliverability. In addition to the drug compound zotarolimus (ABT-578), Endeavor is coated with phosphorylcholine, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, leading to an ideal healing response.
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.
Caution: In the United States, the Endeavor drug-eluting Coronary Stent is an investigational device with an investigational drug (zotarolimus, ABT-578) and exclusively for clinical investigation.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.
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