Medtronic Completes Patient Enrollment
In Endeavor III Clinical Trial
SANTA ROSA, Calif. – September 16, 2004 – Medtronic, Inc. (NYSE: MDT) today announced it has completed patient enrollment in the ENDEAVOR III Clinical Trial in the United States. The data from the ENDEAVOR III trial will be used to support product approval in the United States.
“We are pleased to have completed yet another important milestone in our ENDEAVOR clinical program,” said Scott Ward, president of Medtronic Vascular. “These patients will now be evaluated over the next eight to nine months and will provide important data on the safety and efficacy of the Endeavor™ Drug Eluting Coronary stent. We are confident that this trial will successfully meet its endpoints, particularly the primary endpoint of in-segment late lumen loss at eight months.”
The ENDEAVOR III Clinical Trial is a randomized trial evaluating the safety and efficacy of the Endeavor Drug Eluting Coronary Stent versus the Cypher® Sirolimus-eluting stent marketed by Cordis Corporation, a Johnson & Johnson company. The ENDEAVOR III study is an equivalency study including 436 patients (327 receiving the Endeavor stent) with a primary endpoint of in-segment late lumen loss at eight months. Secondary endpoints include Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR) and Target Vessel Failure (TVF) rates at nine months, and Angiographic Binary Restenosis (ABR) rate at eight months. The co-principal investigators of ENDEAVOR III are Martin B. Leon, M.D., of Columbia University Hospital, New York, and David E. Kandzari, M.D., Duke University Medical Center, Durham, N.C.
ENDEAVOR III is the third in a series of clinical studies designed to gather comprehensive data on the safety and efficacy of the Endeavor Drug Eluting Coronary Stent. The data are being gathered to support product approvals globally. Medtronic has completed patient enrollment in the ENDEAVOR I, ENDEAVOR II and ENDEAVOR II Safety Registry trials and is completing patient follow up as determined for each trial. Medtronic announced on August 18 that it would conduct a fourth trial, named ENDEAVOR IV.
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.
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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