Medtronic enrolls first patient in trial for Endeavor's next generation drug-eluting stent

By E. Janene Geiss

Philadelphia, Dec. 13 - Medtronic, Inc. announced Tuesday the initial use of its next-generation drug-eluting stent, 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 in a clinical trial was enrolled last week at Monash Medical Center in Melbourne, Australia, according to a company news release.

"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," Scott Ward, Medtronic vascular president, said in the release.

"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," he said.

The 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, officials said.

Ian Meredith of Monash Medical Centre is the principal investigator of the first-in-man study, which 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," Meredith said. "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."

Last month Medtronic announced that it filed its first pre-market approval module for Endeavor with the U.S. Food and Drug Administration. This was the first of four pre-market approval modules the company will submit to the FDA, leading to anticipated U.S. approval of the Endeavor stent in 2007, officials said.

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 said it will have safety and efficacy data for approximately 10,000 patients who have received the Endeavor drug-eluting stent.

Medtronic is a Minneapolis, Minn., medical technology company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.