Medtronic Completes Enrollment In International Post-Market Study Of Resolute Drug-Eluting Stent

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 15 May 2009 - 6:00 PDT

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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 experience and understanding of the Resolute DES in the setting of standard clinical practice, which affords a degree of diversity in patient types and lesion characteristics that are typically not well represented in tightly controlled clinical trials," said Prof. Dr. Franz-Josef Neumann of the Heart Center of Bad Krozingen in Germany on behalf of his co-principal investigators, Drs. Petr Widimský of the Faculty Hospital of Kralovske Vinohrady in Prague and Jorge Belardi of the Cardiovascular Institute of Buenos Aires. "Together with other data from the Resolute clinical program, we expect the findings from RESOLUTE International to help physicians make the best possible treatment decisions for the spectrum of patients they see daily."

RESOLUTE International is a prospective, multicenter observational study with a composite primary endpoint of cardiac death 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 enroll a total of more than 6,000 patients at hundreds of clinical research sites in more than 25 countries.

The Resolute DES draws on the strengths of Medtronic's Endeavor DES. The products share the same cobalt alloy stent platform and the potent antiproliferative drug zotarolimus. Both stents also feature highly biocompatible polymers. The Resolute DES uses the BioLinx™ polymer, Medtronic's proprietary polymer designed specifically for use on a DES. The BioLinx polymer is designed to extend the duration of drug exposure in the vessel - an elution profile of potential relevance to patients that physicians consider to be at high risk of needing a repeat procedure - without trading off polymer biocompatibility.

The Resolute DES received the CE (Conformité Européene) mark in October 2007 and is commercially available in more than 100 countries worldwide. Approximately 100,000 patients have been treated with the Resolute DES since its international launch. Use of the Resolute DES in the United States is limited to investigational clinical trials. The Resolute DES is part of Medtronic's broad coronary stents portfolio, which also includes the Endeavor Sprint DES and the Driver and Micro-Driver Bare-Metal Stent.

Source
Medtronic

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