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Medtronic Announces First Patient Enrollment in the ENDEAVOR IV Clinical Trial
Data Will Be Used to Support U.S. Product Approval SANTA ROSA, CA, April 12, 2005 -- Medtronic, Inc. (NYSE:MDT) today announced that enrollment has begun in its ENDEAVOR IV Clinical Trial, the final phase of its ENDEAVOR Clinical Program to be used in support of U.S. Pre-Market Approval (PMA) approval. The first patient implant in the trial was performed yesterday by Charles O'Shaughnessy, M.D., at EMH Regional Medical Center, Elyria, Ohio. "I am personally excited to see this important trial get underway so that we can continue to broaden our clinical experience with drug eluting stents," said Dr. O'Shaughnessy, North Ohio Research, part of the North Ohio Heart Center. "The clinical data presented thus far on the Endeavor stent indicates that this stent system provides a sound combination of safety and efficacy results with exceptional deliverability characteristics, and I look forward to conducting further analysis with the Endeavor system versus a paclitaxel-based drug eluting stent in ENDEAVOR IV." "The start of ENDEAVOR IV marks another important milestone in our program as we seek to bring an additional drug eluting stent alternative to physicians and patients in the United States and around the world," said Scott Ward, president of Medtronic's Vascular division. "This trial, combined with the previous ENDEAVOR clinical trials, will provide a very complete picture of Endeavor's performance in patients, and we look forward to the results." The ENDEAVOR IV Clinical Trial is a randomized, single-blind trial evaluating the safety and efficacy of the Endeavor Drug Eluting Coronary Stent as compared to the TAXUS Paclitaxel-Eluting Coronary Stent System from Boston Scientific Corporation (NYSE:BSX). The ENDEAVOR IV study will include approximately 1,548 patients randomized one-to-one against the TAXUS stent and will be performed at approximately 80 centers in the U.S. and Canada. The primary endpoint of the trial is Target Vessel Failure (TVF) at nine months, with a secondary endpoint of Major Adverse Cardiac Events (MACE) at 30-days. The trial includes angiographic and Intravascular Ultrasound (IVUS) follow-up at eight months for a subset of 328 patients. The co-principal investigators of the ENDEAVOR IV trial are Martin B. Leon, M.D. Columbia University Hospital, New York, and David M. Kandzari, M.D., Duke University Medical Center, Durham, N.C. The ENDEAVOR Clinical Trial Program The ENDEAVOR Clinical Program includes a series of studies designed to collect substantial amounts of clinical, angiographic and IVUS data on Medtronic's investigational Endeavor Drug Eluting Coronary Stent for evaluation of the safety and effectiveness in reducing restenosis. The ENDEAVOR I Clinical Trial was a 100-patient, prospective, multi-center trial studying the safety and efficacy of the Endeavor Drug Eluting Stent for the treatment of de novo coronary lesions in native coronary arteries. The trial was conducted at sites in Australia and New Zealand. The Endeavor stent demonstrated positive 12-month clinical results, including a MACE rate of only 2.0 percent; a Target Lesion Revascularization (TLR) rate of only 1.0 percent, and an Angiographic Binary Restenosis (ABR) rate of 5.4 percent. The ENDEAVOR II Pivotal Clinical Trial completed enrollment of 1,197 patients in January 2004. ENDEAVOR II was a randomized, double-blind trial evaluating the safety and efficacy of the Endeavor Drug Eluting Coronary Stent compared to Medtronic's original Driver(TM) Cobalt Alloy Coronary Stent System in patients with coronary artery disease. The data from the trial will be used to support product approvals in various countries. The study's excellent clinical results were presented in March at the American College of Cardiology (ACC) annual conference in Orlando, Fla. The ENDEAVOR II study demonstrated clinically and statistically significant improvement in all of the study's endpoints, including a 47 percent reduction in the primary endpoint of Target Vessel Failure (TVF). The study demonstrated a Target Lesion Revascularization (TLR) rate of only 4.6 percent and a MACE rate of 7.4 percent. The ENDEAVOR II data included impressive safety results, including no late malapposition and no late thrombosis beyond thirty days. The ENDEAVOR III Clinical Trial is a randomized trial evaluating the safety and efficacy of the Endeavor(TM) Drug Eluting Stent as compared to the Cypher(R) Sirolimus-eluting stent marketed by Cordis Corporation, a Johnson & Johnson company. The study completed enrollment of its 436 patients (327 receiving the Endeavor stent) in September 2004, and has a primary endpoint of in-segment late lumen loss at eight months. Results from the ENDEAVOR III Clinical Trial are expected to be presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in October 2005. Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com. Caution: The Endeavor Drug Eluting Coronary Stent is an investigational device. The device is limited by federal (or United States) law to investigational use only. ABT-578 is an investigational drug and is not approved by the FDA. 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 30, 2004. Actual results may differ materially from anticipated results. Contacts: Medtronic Vascular Public Relations: Rob Clark, 707-591-7979 or Medtronic Investor Relations: Rachael Scherer, 763-505-2694 Medtronic, Inc. |
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