Medtronic Submits First PMA Module To The U.S. Food And Drug Administration For Endeavor™ Drug-Eluting Coronary Stent
Module submission is first step in U.S. approved process
MINNEAPOLIS – Oct. 11, 2005 – Medtronic (NYSE: MDT) announced that it has submitted its first Pre-Market Approval (PMA) module to the U.S. Food and Drug Administration for the Endeavor™ Drug-Eluting Coronary Stent system. This action represents the first step by Medtronic in the U.S. approval process for Endeavor stents.
Scott Ward, president of Medtronic Vascular in Santa Rosa, Calif., said the company has worked diligently with the FDA to develop a well-designed schedule of modular submissions that meet the agency’s requirements for the Endeavor stent and the new molecular entity, ABT-578. The modules will reflect the depth of the entire Endeavor clinical trial program, including key safety data from the current ENDEAVOR IV trial. By the time the final PMA module is submitted, Medtronic will have safety and efficacy data on more than 2,000 patients implanted with the Endeavor stent.
“This is the first of four PMA modules that we will file with the FDA over the coming year,” Ward said. “We are preparing a thorough and comprehensive dossier that reflects Endeavor’s extensive pre-clinical and clinical experience. We will submit the final PMA module when we have sufficient data to support the key safety and efficacy claims for the Endeavor Drug-Eluting Coronary Stent System.”
The Endeavor stent, which received regulatory approval from the European Commission in July 2005, is made of a cobalt alloy and has a unique modular architecture designed to enhance deliverability over standard bare metal stents. In addition to the proprietary drug compound ABT-578, the Endeavor stent is coated with phosphorylcholine (PC), a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane.
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: The Endeavor Drug Eluting Coronary Stent is an investigational device with an investigational drug (ABT-578) exclusively for clinical investigation.
Note: The drug ABT-578 is licensed under patents or patent applications owned by Abbott Laboratories, Inc. The PC Technology is licensed under patents or patent applications by Biocompatibles.
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 29, 2005. Actual results may differ materially from anticipated results.
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