Medtronic Announces First Clinical Trial Experience With Next-Generation Drug-Eluting Coronary Stent System
MINNEAPOLIS – Dec. 13, 2005 – Medtronic, Inc. (NYSE: MDT) today announced the initial clinical trial use of its next-generation drug-eluting stent (DES), a system that offers an extended drug exposure designed for longer healing times that may be particularly appropriate for complex lesions. The first patient to receive this new stent was enrolled last week at Monash Medical Centre in Melbourne, Australia.
“Based on data from more than 1,300 patients who have received the Endeavor™ drug-eluting stent in our robust clinical programs, we are quite pleased with the performance of the product and patients are doing well,” said Scott Ward, Medtronic Vascular president. “Our next generation drug-eluting stent will leverage the strengths of Endeavor with a new polymer that allows us to optimize drug exposure for precise and durable therapy in even the most challenging clinical conditions.”
This next-generation drug-eluting stent will use the popular Driver™ bare metal cobalt alloy stent platform and the drug Zotarolimus (ABT-578), along with the proprietary, biocompatible drug delivery polymer developed by Medtronic. Prof. Ian Meredith, Monash Medical Centre, is the principal investigator of the Medtronic RESOLUTE clinical study evaluating the new stent. This first-in-man study will enroll up to 100 patients at 12 clinical sites in Australia and New Zealand.
“Until now we’ve been treating all patients with about the same drug dose exposure, but we know there is delayed healing in many patients who have diabetes or complex lesions,” said Prof. Meredith. “We’re trying to address that problem with a longer duration of drug response. Our goal is to improve clinical outcomes, while maintaining the high level of efficacy and sustained safety profile we currently see with the Endeavor drug-eluting stent.”
Medtronic’s drug-eluting stent program has gained considerable momentum in recent months. Since March, the company has presented encouraging clinical data for the pivotal ENDEAVOR II study, the ENDEAVOR II Continued Access Registry, and the confirmatory ENDEAVOR III study, as well as consistent longer-term data from ENDEAVOR I and ENDEAVOR II. The Endeavor DES system received CE Mark approval in late July and has been successfully launched in more than 85 countries around the world.
In addition, last month Medtronic announced that it filed its first pre-market approval (PMA) module for Endeavor with the U.S. Food and Drug Administration. This was the first of four PMA modules the company will submit to the FDA, leading to anticipated U.S. approval of the Endeavor stent in 2007. Medtronic also began the 8,000-patient ENDEAVOR V international patient registry in October. With this registry and the results from four Endeavor clinical studies, Medtronic will have safety and efficacy data for approximately 10,000 patients 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 the world.
This press release contains forward-looking statements, including statements
regarding anticipated regulatory approval and study completion dates, which are
subject to risks and uncertainties, such as governmental regulation, general
economic conditions and others described in Medtronic’s Quarterly Report on Form
10-Q for the quarter ended October 28, 2005. Actual results may differ materially
from anticipated results. Medtronic does not undertake to update its forward-looking
statements.
Caution: The Endeavor Drug Eluting Coronary stents are investigational devices with an investigational drug (ABT-578) and exclusively for clinical investigation.
Source: Medtronic, Inc. |
