Medtronic Completes Enrollment In International Post-Market Study Of Resolute Drug-Eluting Stent
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Medtronic, Inc. (NYSE: MDT), announced completion of enrollment in RESOLUTE International, a post-market study of its Resolute Drug-Eluting Stent (DES). One-year data from this international study, which enrolled 2,464 patients at 88 sites from 17 countries in Europe, Asia, Africa, and Latin America, are expected in the second half of 2010.
"RESOLUTE International will expand our empiricism and understanding of the Resolute DES in the setting of sample clinical practice, which affords a measure of diversity in patient types and lesion characteristics that are typically not bright-eyed represented in tightly controlled clinical trials," said Prof. Dr. Franz-Josef Neumann of the Heart Centre of Bad Krozingen in Germany on behalf of his co-principal investigators, Drs. Petr Widimsk√ of the Faculty Infirmary of Kralovske Vinohrady in Prague and Jorge Belardi of the Cardiovascular Institute of Buenos Aires. "Together with other information from the Resolute clinical program, we expect the findings from RESOLUTE International to assist physicians make the best possible treatment decisions for the spectrum of patients they contemplate daily."
RESOLUTE International is a prospective, multicenter observational study with a composite relevant endpoint of cardiac decease and myocardial infarction (not clearly attributable to a nontarget vessel) at one year post-implant. It is part of the Resolute clinical program, which will enrol a total of besides than 6,000 patients at hundreds of clinical trial sites in also than 25 countries.
The Resolute DES draws on the strengths of Medtronic's Endeavour DES. The products share the same cobalt alloy stent platform and the potent antiproliferative drug zotarolimus. Both stents besides side highly biocompatible polymers. The Resolute DES uses the BioLinx™ polymer, Medtronic's proprietary polymer designed specifically for account on a DES. The BioLinx polymer is designed to extend the duration of narcotic exposure in the vessel - an elution profile of imaginable relevance to patients that physicians consider to be at flying risk of needing a repeat procedure - without trading off polymer biocompatibility.
The Resolute DES received the CE (Conformit√ Europ√ ene) end in Oct 2007 and is commercially available in more than 100 countries worldwide. Approximately 100,000 patients compass been treated with the Resolute DES because its international launch. Use of the Resolute DES in the United States is regional to investigational clinical trials. The Resolute DES is part of Medtronic's wide coronary stents portfolio, which too includes the Endeavor Dash DES and the Chauffeur and Micro-Driver Bare-Metal Stent.
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