13.12.2005 14:00:00
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Medtronic Announces First Clinical Trial Experience with Next-Generation Drug-Eluting Coronary Stent System
"Based on data from more than 1,300 patients who have received theEndeavor(TM) drug-eluting stent in our robust clinical programs, weare quite pleased with the performance of the product and patients aredoing well," said Scott Ward, Medtronic Vascular president. "Ournext-generation drug-eluting stent will leverage the strengths ofEndeavor with a new polymer that allows us to optimize drug exposurefor precise and durable therapy in even the most challenging clinicalconditions."
This next-generation drug-eluting stent will use the popularDriver(TM) bare metal cobalt alloy stent platform and the drugZotarolimus (ABT-578), along with the proprietary, biocompatible drugdelivery polymer developed by Medtronic. Prof. Ian Meredith, MonashMedical Centre, is the principal investigator of the MedtronicRESOLUTE clinical study evaluating the new stent. This first-in-manstudy will enroll up to 100 patients at 12 clinical sites in Australiaand New Zealand.
"Until now we've been treating all patients with about the samedrug dose exposure, but we know there is delayed healing in manypatients who have diabetes or complex lesions," said Prof. Meredith."We're trying to address that problem with a longer duration of drugresponse. Our goal is to improve clinical outcomes, while maintainingthe high level of efficacy and sustained safety profile we currentlysee with the Endeavor drug-eluting stent."
Medtronic's drug-eluting stent program has gained considerablemomentum in recent months. Since March, the company has presentedencouraging clinical data for the pivotal ENDEAVOR II study, theENDEAVOR II Continued Access Registry, and the confirmatory ENDEAVORIII study, as well as consistent longer-term data from ENDEAVOR I andENDEAVOR II. The Endeavor DES system received CE Mark approval in lateJuly and has been successfully launched in more than 85 countriesaround the world.
In addition, last month Medtronic announced that it filed itsfirst pre-market approval (PMA) module for Endeavor with the U.S. Foodand Drug Administration. This was the first of four PMA modules thecompany will submit to the FDA, leading to anticipated U.S. approvalof the Endeavor stent in 2007. Medtronic also began the 8,000-patientENDEAVOR V international patient registry in October. With thisregistry and the results from four Endeavor clinical studies,Medtronic will have safety and efficacy data for approximately 10,000patients who have received the Endeavor drug-eluting stent.
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.
This press release contains forward-looking statements, includingstatements regarding anticipated regulatory approval and studycompletion dates, which are subject to risks and uncertainties, suchas governmental regulation, general economic conditions and othersdescribed in Medtronic's Quarterly Report on Form 10-Q for the quarterended October 28, 2005. Actual results may differ materially fromanticipated results. Medtronic does not undertake to update itsforward-looking statements.
Caution: The Endeavor Drug Eluting Coronary stents areinvestigational devices with an investigational drug (ABT-578) andexclusively for clinical investigation.
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