Healthcare Industry News: stent thrombosis
News Release - November 16, 2006
Medtronic Submits Final PMA Modules to FDA for Approval of the Endeavor Drug-Eluting Coronary Stent SystemLargest Clinical Dossier Ever Submitted to FDA for a Drug-Eluting Stent
MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) today announced that it has submitted the final modules of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration for the EndeavorŪ drug-eluting coronary stent system. Medtronic's PMA submission includes safety and efficacy data on approximately 4,100 patients who have been treated with Endeavor in clinical trials that include follow up for as long as three years. The Endeavor PMA sets a new standard for clinical data submitted to the FDA, with data from the largest, most wide-ranging patient population and for patients with the longest follow-up ever submitted to support the safety and efficacy of a new drug-eluting stent (DES).
"We've submitted an extremely robust dossier on the Endeavor drug-eluting stent, and we look forward to working with the FDA on an expeditious PMA review," said Scott Ward, president of the Vascular business at Medtronic. "Endeavor represents a new generation of drug-eluting stents, with a polymer-drug combination specifically designed to reduce restenosis while maintaining a favorable safety profile. We have submitted a PMA that strongly supports the safety and efficacy criteria needed for U.S. approval."
Patient follow-up in the Endeavor clinical trials has been extensive. The number of patients included in the Endeavor PMA is nearly double the number of the two commercially available drug-eluting stents combined at the time of their submission. The Endeavor PMA includes safety and efficacy data from the following major clinical trials or registries:
the ENDEAVOR I first-in-man study the ENDEAVOR II randomized, controlled trial comparing the performance of the Endeavor drug-eluting stent to the Medtronic DriverŪ bare metal stent the ENDEAVOR II Continued Access study the ENDEAVOR III and ENDEAVOR IV randomized, controlled trials comparing Endeavor against both of the DES products commercially available in the United States the E-Five post-market registry conducted outside the United States "This is a substantial and impressive PMA that is supported by data from several large and well-designed clinical trials," said Dr. Martin B. Leon, founder of the Cardiovascular Research Foundation, professor of medicine at Columbia University Medical Center and a principal investigator for the ENDEAVOR III and ENDEAVOR IV trials. "The performance of the Endeavor stent has been very consistent, and its safety and efficacy have been well characterized through the cumulative data from its clinical trial program."
Following a PMA submission, the FDA typically takes several actions during its review cycle of new medical technology products. This includes reviewing the PMA documents, inspecting the Endeavor manufacturing facilities at Medtronic's Santa Rosa, Calif. and Galway, Ireland locations, scheduling an optional advisory panel meeting, and determining final product labeling. Medtronic anticipates that the FDA will require a panel meeting.
Medtronic reported excellent patient safety data at last month's Transcatheter Cardiovascular Therapeutics (TCT) symposium in Washington, D.C., an annual meeting of global interventional cardiologists. In addition, data published recently in the medical journal CIRCULATION demonstrated excellent clinical outcomes in the ENDEAVOR II pivotal trial, with sustained efficacy, low rates of adverse events and outstanding stent deliverability.
"With extensive clinical data now published in peer-reviewed journals, the Endeavor drug-eluting stent has demonstrated excellent clinical outcomes and we continue to be very encouraged by the product's safety profile," said Ward, who noted that under the pre-specified definitions used in the company's clinical trial protocols, Endeavor has an overall thrombosis rate of 0.3 percent, with zero late stent thrombosis. "The data is unambiguous and shows that no matter what type of analyses are used, Endeavor provides the clinical outcomes physicians expect from a drug-eluting stent, with the safety they expect from a bare metal stent."
The Endeavor stent, which received CE Mark in 2005 and is currently commercially available in more than 100 countries worldwide, is made of a cobalt alloy with a unique modular architecture designed to enhance deliverability. In addition to the potent cytostatic drug, zotarolimus, Endeavor is coated with phosphorylcholine (PC Coating), a biocompatible polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, leading to an optimal healing response around the stent following implantation.
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.
Caution: In the United States, the Endeavor drug-eluting Coronary Stent is an investigational device with an investigational drug (zotarolimus, ABT-578) and is used exclusively for clinical investigation. PC Coating is licensed under patents owned by Biocompatibles, UK Ltd.
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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