Healthcare Industry News: stent thrombosis
News Release - June 27, 2006
Medtronic Announces Completion of Patient Enrollment in ENDEAVOR IV Clinical TrialEnrollment Also Complete in ENDEAVOR-Japan and RESOLUTE Clinical Studies
MINNEAPOLIS--(HSMN NewsFeed)--June 27, 2006--Medtronic, Inc. (NYSE:MDT ) today announced that it has completed patient enrollment in the ENDEAVOR IV clinical study, paving the way for final data evaluation of the EndeavorŪ drug-eluting coronary stent (DES) system and ultimate submission to the United States Food and Drug Administration for U.S. approval. At the same time, Medtronic also said it has completed enrollment in two other important clinical trials: the RESOLUTE study evaluating the company's next-generation DES product and the ENDEAVOR-Japan study evaluating the Endeavor stent at 12 clinical sites in Japan.
"Completion of patient enrollment in these three trials is a tremendous achievement for the Endeavor clinical program," said Scott Ward, president of Medtronic's vascular business. "Along with the data from our previous Endeavor trials, the results of the ENDEAVOR IV study will provide a very comprehensive picture of Endeavor's clinical performance. Never before has a drug-eluting stent been subjected to such a rigorous examination prior to approval. We look forward to the results of ENDEAVOR IV and continuing with a regulatory pathway that will bring the Endeavor stent to market in the United States."
The ENDEAVOR IV study is part of an extensive clinical program that also includes the ENDEAVOR I, II and III trials. Together, these trials will provide safety and efficacy data on more than 2,000 patients who have had the Endeavor stent implanted over the past 42 months, and this data will be used to support Medtronic's Pre-Market Approval (PMA) submission to the FDA. Medtronic also is conducting an 8,000-patient international registry known as "e-FIVE" outside the United States.
Along with ENDEAVOR III, the ENDEAVOR IV trial is Medtronic's second major randomized clinical trial conducted in the U.S., unprecedented among DES manufacturers. ENDEAVOR III results showed that the Endeavor stent had comparable clinical outcomes to the Cypher stent made by Johnson and Johnson/Cordis, and it also confirmed in a U.S. patient population the positive clinical outcomes seen in the international ENDEAVOR II pivotal trial. In the ENDEAVOR IV trial, Endeavor is going head-to-head against the TAXUS stent made by Boston Scientific. The co-principal investigators for both of these trials are Martin B. Leon, M.D. Columbia University Hospital, New York, and David E. Kandzari, M.D., Duke University Medical Center, Durham, N.C.
"Few drug-eluting stents have been studied with this degree of rigor against existing, approved DES technologies," said Dr. Leon. "Compared to ENDEAVOR III, the endpoints for ENDEAVOR IV favor clinical results over angiographic results, which more closely parallels the way physicians actually practice medicine. Data from ENDEAVOR IV should provide a clear indication of how the Endeavor stent compares to what has been the U.S. market leader."
ENDEAVOR IV is evaluating 1,548 patients at 80 clinical centers in the United States, with a primary endpoint of Target Vessel Failure (TVF) at nine months and 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 results from this trial will help clarify the safety and efficacy profile of the Endeavor stent, and it also should broaden physicians' selection and preference patterns when it comes to drug-eluting stents," said Dr. Kandzari. "Results from the first three Endeavor studies have been excellent and ENDEAVOR IV should really bring everything into focus. It will complete a substantial and impressive data dossier on the Endeavor stent for presentation to the FDA."
Recent long-term data presented at the Paris Course on Revascularization (EuroPCR) in May provided evidence that the Endeavor stent is performing as well, or better, than other drug-eluting stents that are commercially available in the U.S. This data demonstrated low rates of both repeat procedures (Target Lesion Revascularization, or TLR) and major adverse clinical events (MACE) such as death and myocardial infarction. (see Medtronic news release dated May 16, 2006: "Impressive Clinical Results Show Medtronic Endeavor Drug-Eluting Coronary Stent Provides Significant Long-Term Safety and Efficacy Benefits")
The combined TLR rate for Endeavor patients in all of the trials is just 4.9%, which means that more than 95% of the 1,300 Endeavor patients followed for at least one year have not needed a repeat procedure. In addition, results from the large ENDEAVOR II pivotal study at two years showed a MACE rate of just 10.0%, which compares favorably to currently approved DES products. Also, there have been no observations of late stent thrombosis - the formation of dangerous blood clots that can potentially lead to heart attacks or death - in Endeavor trials stretching out to three years.
Made of a cobalt alloy with a unique modular architecture designed to enhance deliverability, Endeavor received CE Mark in July 2005 and is available in approximately 100 countries worldwide. It is not yet approved in the United States. However, Medtronic filed its first PMA module in October 2005 and the company anticipates FDA approval in calendar year 2007.
The RESOLUTE study enrolled 130 patients at 12 clinical sites in Australia and New Zealand. Medtronic's next generation drug-eluting stent uses the same stent platform and drug as the Endeavor stent (the DriverŪ bare metal cobalt alloy stent and Zotarolimus, or ABT-578), but incorporates a proprietary, biocompatible drug delivery polymer developed by Medtronic instead of PC Polymer licensed from Abbott. This will allow Medtronic to leverage the strengths of Endeavor with the new polymer to extend the duration of drug in the vessel wall, addressing the delayed healing response in patients who have challenging clinical conditions. Prof. Ian Meredith, Monash Medical Centre, Melbourne, Australia, is the principal investigator for RESOLUTE.
The Endeavor-Japan clinical trial is a single-arm, prospective multi-center study with 99 patients and a primary endpoint of TVF at 9 months. The Principal Investigator is Dr. Shigeru Saito, Assistant Director of Cardiology at Shonan Kamakura General Hospital in Kanagawa, Japan. Data from this trial will be evaluated by the Duke Clinical Research Institute and final results will be submitted to Japan's Ministry of Health, Labor and Welfare for ultimate approval in that country.
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 exclusively for clinical investigation.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.
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