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Medtronic Provides Details on the ENDEAVOR IV Clinical Trial.

MUNICH, Germany -- Randomized Trial to Compare Endeavor(TM) Drug Eluting Coronary Stent to TAXUS(TM)

David E. Kandzari, M.D., the Co-Principal Investigator for the ENDEAVOR IV Clinical Trial, presented details on the proposed design of the ENDEAVOR IV Clinical Trial today at the European Society of Cardiology (ESC) conference. ENDEAVOR IV, sponsored by Medtronic, Inc. (NYSE:MDT), will be the fourth in a series of clinical studies to support global product approval of Medtronic's investigational Endeavor(TM) Drug Eluting Coronary Stent. The ENDEAVOR IV trial will be conducted at approximately 70 sites throughout the U.S. Medtronic intends to begin ENDEAVOR IV patient enrollment in October.

The ENDEAVOR IV Clinical Trial will be a randomized, single-blind trial evaluating the safety and efficacy of the Endeavor(TM) Drug Eluting Coronary Stent as compared to the TAXUS(TM) Paclitaxel-Eluting Coronary Stent System from Boston Scientific Corporation. The ENDEAVOR IV study will include approximately 900 patients randomized three to one against the TAXUS stent. 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 patients. The co-principal investigators of ENDEAVOR IV are Martin B. Leon, M.D., of Columbia University Hospital, New York, N.Y., and David E. Kandzari, M.D., Duke University Medical Center, Durham, N.C.

"This ENDEAVOR IV trial design offers a number of important advantages to Medtronic as it seeks product approval of the Endeavor stent in the United States," said Dr. Kandzari. "Upon completion of this trial, Medtronic will have important comparative data against the TAXUS stent in addition to data gathered on the Cypher stent from Johnson & Johnson in the ENDEAVOR III trial. Furthermore, this trial will provide safety data on more than 2,000 patients requested by the FDA for a new molecular entity, further strengthening Medtronic's product approval submission. Finally, since the trial inclusion criteria allows for multi-vessel treatment to reflect a broad clinical population, we expect the protocol design should facilitate swift patient enrollment in the trial."

"As communicated earlier, Medtronic and the FDA have discussed this trial design and the general framework of the ENDEAVOR IV trial, which will be submitted to the FDA for approval," said Scott Ward, president of Medtronic Vascular. "This approach is designed to let us secure the important safety and efficacy data required for submission of our PMA and should further enable us to meet our goal of PMA submission in the summer of 2005."

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 is 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 began in 2003 and was conducted at sites in Australia and New Zealand. ENDEAVOR I 12-month results were presented today at ESC and at the EuroPCR conference in Paris in May. The clinical 12-month results released today include a MACE rate of 2.0 percent; a 12-month cumulative Angiographic Binary Restenosis (ABR) rate of 5.4 percent; TLR rate of 1.0 percent; an in-segment late lumen loss of 0.43 mm and an in-stent late lumen loss of 0.61 mm.

The ENDEAVOR II Pivotal Clinical Trial completed enrollment of 1,200 patients in January 2004. ENDEAVOR II is a randomized, double-blind trial that will evaluate the safety and efficacy of the Endeavor Drug-Eluting Stent compared to the Driver(TM) cobalt alloy stent and will support product approvals in various countries. The primary endpoint of the study is the TVF rate at nine months. Nine-month clinical results on ENDEAVOR II will be presented at the American College of Cardiology (ACC) conference in March 2005. The ENDEAVOR II Continued Access Registry completed enrollment of an additional 300 patients in July and will provide additional safety and efficacy data for product approvals globally.

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 will enroll 436 patients (327 receiving the Endeavor stent) and has a primary endpoint of in-segment late lumen loss at eight months. Secondary endpoints include TLR, TVR, and TVF rates at nine months and Angiographic Binary Restenosis (ABR) rate at eight months.

Components of Medtronic's Endeavor Drug Eluting Stent Program

The Medtronic Endeavor Drug Eluting Coronary Stent system combines Medtronic's Driver Coronary Stent, the drug ABT-578 and a PC polymer into a drug eluting stent system designed to reduce restenosis.

ABT-578 is a unique, patent-protected compound licensed to Medtronic by Abbott Laboratories. ABT-578 is designed to inhibit the cellular process that leads to restenosis. Medtronic also licenses Abbott's proprietary phosphorylcholine coating technology (PC Technology(TM) is licensed under patents owned by Biocompatibles, Ltd.). PC Technology is designed to serve as the "delivery matrix," which controls the elution, or release, of ABT-578 directly into the arterial wall. Finally, Medtronic's Endeavor stent system utilizes the original Driver Coronary Stent, which is approved in both the United States and Europe for treating large and small vessels (small vessels outside the U.S. only). The Driver Coronary Stent leverages Medtronic's long expertise in utilizing implantable metal alloys, such as cobalt chromium alloys. Medtronic's Driver cobalt alloy stent is designed to allow for thinner struts, a lower profile and better deliverability in the vessel without compromising radial strength and visibility.

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

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 statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements 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.
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Publication:Business Wire
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Date:Aug 31, 2004
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