Healthcare Industry News: drug-eluting stent
News Release - October 4, 2006
Medtronic Announces Regulatory Approval for the Endeavor Drug-Eluting Coronary Stent System in AustraliaFirst Commercial Implant Occurs at Monash Medical Centre in Melbourne
MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) today announced that it has received regulatory approval from Australia's Therapeutic Goods Administration to begin selling the EndeavorŪ drug-eluting coronary stent (DES) system. The first commercial implants occurred this week at Monash Medical Centre in Melbourne. Monash Medical Centre and several other clinical sites throughout Australia and New Zealand initiated the Endeavor "first-in-man" experience in early 2003.
With the approval in Australia, the Endeavor stent is now commercially available in more than 100 countries worldwide. The stent is currently in clinical evaluation in the U.S., with FDA approval anticipated in 2007. As a true next-generation drug-eluting stent with a drug-polymer combination that helps allow healthy healing of blood vessels following stent implant, Endeavor has demonstrated excellent clinical effectiveness and safety in its clinical trials.
"The approval of the Endeavor drug-eluting stent is an important event for physicians and patients in Australia, as it brings a new medical technology to thousands of patients who suffer from cardiovascular disease," said Dr. Ian T. Meredith, Professor of Medicine at Monash Medical Centre, who performed the first commercial implant. "I have followed the data for Endeavor very closely over the past three years and it has provided impressive clinical outcomes. The stent is effective at reducing restenosis and it has been proven to be among the safest stents on the market."
Prof. Meredith is the Principal Investigator for ENDEAVOR I, the first study in a multi-phase clinical trial program evaluating the Endeavor stent. "Australia has been at the forefront of cutting-edge medical research for many years and I'm proud of the role the clinical centers have played in the development of this medical technology," Prof. Meredith said. "The diligent work of the Endeavor investigators in Australia has been instrumental in the success of this clinical trial."
Approximately 38,000 stents are implanted in Australian patients each year. Max Muhs, vice president of Medtronic's vascular business in AsiaPacific, said that the Endeavor stent would be available immediately. "We're ready to supply the Australian market and very proud to make the Endeavor stent available to physicians and patients here," Muhs said. "With its outstanding deliverability and excellent clinical data, we feel the Endeavor stent can make a real difference in clinical practices in Australia."
Long-term data published recently in CIRCULATION magazine demonstrated excellent clinical outcomes for the Endeavor stent, with sustained efficacy, low rates of adverse events and outstanding deliverability. Endeavor's Target Lesion Revascularization (TLR) rate at two years is just 6.5 percent and consistent in all patient subgroups. Endeavor's stent thrombosis rate is 0.3 percent, with no late stent thrombosis events in more than 1,300 patients followed out to three years. In addition, the 1,200-patient ENDEAVOR II pivotal trial showed that Endeavor was safer in a composite of death and myocardial infarction than the Driver bare metal stent control arm.
The Endeavor drug-eluting stent is made of a cobalt alloy and is built on the same platform as the popular Medtronic DriverŪ bare metal stent, with a unique modular architecture designed to enhance deliverability. In addition to the drug compound zotarolimus (ABT-578), Endeavor is coated with phosphorylcholine, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, leading to an ideal healing response.
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 Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
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