Healthcare Industry News: Biostat
News Release - December 8, 2006
Medtronic Presents Data on Next Generation Endeavor(R) Drug-Eluting Stent at Special FDA Panel Meeting on DES SafetyCombination of Drug, Polymer and Stent Platform Designed to Help Healing
MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) today presented safety and efficacy data from the company's extensive EndeavorŪ drug-eluting stent clinical trial program at a special U.S. Food and Drug Administration advisory panel meeting convened to discuss growing concerns about drug-eluting stent safety. Specifically, the data demonstrates a significant reduction in the need for repeat procedures compared to bare metal stent controls, and a low rate of stent thrombosis in approximately 1,300 patients followed for two to three years in Endeavor clinical trials.
The Endeavor drug-eluting stent system is an investigational device and not yet approved in the United States. Medtronic submitted its Endeavor Pre-Market Approval (PMA) application on Nov. 16 and anticipates U.S. approval in 2007. The PMA includes safety and efficacy data on approximately 4,100 patients who have been treated with the Endeavor stent. The PMA also reflects data from the largest, most wide-ranging patient population and for patients with the longest follow up ever submitted to support approval of a new drug-eluting stent.
"The safety and efficacy results achieved with the Endeavor drug-eluting stent are impressive and likely driven by key design elements aimed at the healing phase, by combining optimum choices of stent platform, polymer and drug," said Medtronic Sr. Vice President, Richard E. Kuntz, M.D. "Endeavor is a true next-generation stent that reduces the need for repeat procedures while providing ongoing cumulative safety data that is very promising."
Dr. Kuntz is the co-founder of the Harvard Clinical Research Institute (HCRI), where as Chief Scientific Officer he helped direct more than 100 multi-center clinical trials involving approximately 45,000 patients, including most of the major drug-eluting stent trials for DES manufacturers. His expertise in trial design and Biostatistics is well known within industry, academia and government.
At the FDA meeting, Dr. Kuntz provided data regarding the safety of the Endeavor stent using multiple definitions of stent thrombosis. According to the pre-specified clinical trial protocol definitions, the Endeavor stent has an overall thrombosis rate of 0.3 percent, with no stent thrombosis beyond 30 days. Using the broader, proposed stent thrombosis definitions recently created by the independent Academic Research Consortium, Endeavor showed a similarly low stent thrombosis rate of 0.5 percent.
"By any metric, Endeavor has demonstrated a low stent thrombosis rate and an impressive safety profile in a large clinical trial experience," said Dr. Kuntz.
Stents are tiny mesh tubes that prop open previously-blocked arteries following an angioplasty procedure. Endeavor has a unique combination of a non-toxic drug (zotarolimus), a non-inflammatory polymer (PC Coating), and a flexible, modular design using the Medtronic DriverŪ bare metal stent platform. These elements are designed to help promote physiologic compatibility between the stent and the body. The Endeavor stent received CE Mark in 2005 and is currently commercially available in more than 100 countries worldwide.
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.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
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