Healthcare Industry News: Zotarolimus
News Release - May 18, 2006
Endeavor Registry Data Confirms High Deliverability Success and Broad, Everyday Use by Physicians
Includes Difficult to Treat Patients with Complex Lesions and DiabetesPARIS--(HSMN NewsFeed)--May 18, 2006--Prof. Chaim Lotan, M.D., Co-Principal Investigator of the Medtronic e-Five international registry and head of the Hadassah University Hospital Heart Institute, Jerusalem, Israel, today presented preliminary demographic data from the registry confirming that the Endeavor(TM) Drug-Eluting Coronary Stent is being implanted in a broad spectrum of patients during routine clinical practice. This experience includes patients with diabetes, tortuous calcified lesions, and small blood vessels. Prof. Lotan made the presentation during a Medtronic-sponsored symposium at the Paris Course on Revascularization (EuroPCR).
The e-Five registry is an 8,000 patient prospective, multi-center study designed as an "all comers" trial to assess the safety of the Endeavor stent at more than 200 sites in Europe, Asia, Australia, and other locations outside the United States, with a primary endpoint of Major Adverse Cardiac Events (MACE) at one year. The study has enrolled approximately 2,500 patients.
The Endeavor drug eluting coronary stent received CE Mark approval in late July 2005 and is now available in more than 85 countries around the world. The Endeavor stent is not approved for use in the United States. Medtronic filed its first Pre-Market Approval (PMA) module with the U.S. Food and Drug Administration in October 2005. The company remains on track for PMA approval in calendar year 2007.
Prof. Lotan reported that physicians implanting the stent as part of their normal, everyday practice have been successful in delivering the stent to the lesion 99.5 percent of the time. The Endeavor stent is made of a cobalt alloy and has a unique modular architecture designed to enhance deliverability. Prof. Lotan also reported that approximately 35 percent of these patients are afflicted with diabetes and that small vessel sizes - those 2.25 to 2.75 mm in diameter - account for 42 percent of the total Endeavor stents implanted in the registry to date.
"These are important findings because it indicates physicians are comfortable using the Endeavor stent in a wide variety of cases on an everyday basis," he said. "Based on this early look at the data, especially the high delivery success rate, implanting physicians can have confidence that the Endeavor stent will perform well in many types of cases, whether they are routine or in patients with complex medical conditions."
The average stent length in the registry is 17.6 mm, with 1.4 stents implanted per patient. In addition, more than 35 percent of the patients had a previous myocardial infarction and 33 percent had unstable angina at the time of the stent implant. Medtronic (NYSE: MDT ) will present additional results from the registry in the fall.
The other Co-Principal Investigators of the e-Five registry are Prof. Martin Rothman, The London Chest Hospital, London, U.K., and Prof. Ian Meredith, M.D. Monash Medical Centre, Melbourne, Australia.
About Medtronic
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.
Source: Medtronic
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