Healthcare Industry News: stent thrombosis
News Release - May 16, 2006
Impressive Clinical Results Show Medtronic ENDEAVOR(TM) Drug-Eluting Coronary Stent Provides Significant Long-Term Safety and Efficacy BenefitsPositive data presented at EuroPCR demonstrates low rates of repeat procedures and no observations of late stent thrombosis
PARIS--(HSMN NewsFeed)--May 16, 2006--Prof. Ian Meredith, Principal Investigator of the ENDEAVOR I clinical trial and Professor of Medicine, Monash Medical Centre, Melbourne, Australia, today presented impressive long-term clinical results from the Medtronic (NYSE:MDT ) ENDEAVOR I and ENDEAVOR II trials at the Paris Course on Revascularization (EuroPCR). Data from the two studies shows that the Endeavor(TM) drug-eluting coronary stent is continuing to provide significant and sustained efficacy and safety performance over time, with low rates of repeat procedures and no observations of late stent thrombosis.
"Through the dedicated efforts of clinical investigators around the world, these well-designed and robust clinical trials provide compelling evidence characterizing the long-term safety and efficacy of the Endeavor drug-eluting coronary stent," said Prof. Meredith, who presented 3-year data from the 100-patient first-in-man ENDEAVOR I clinical study, and 2-year results from the 1,200-patient, double-blind randomized ENDEAVOR II pivotal trial. "The patient follow-up for both trials was excellent at 97 percent, and the clinical results are impressive, with low rates of restenosis and an excellent safety profile."
The Endeavor stent is showing excellent durability over time, with a low number of clinical events between 2-3 years and between 1-2 years in the respective studies. The ENDEAVOR I trial had a 3-year Target Lesion Revascularization (TLR) rate of just 3 percent, which means 97 percent of the patients who received an Endeavor stent required no further treatment or revascularization at the original treatment site after three years of follow-up. In ENDEAVOR II, 93.5 percent of the Endeavor patients remain free of repeat procedures after two years, with a TLR rate of only 6.5 percent. Target Lesion Revascularization is the rate of re-treatment of a previously stented lesion and is widely viewed by physicians as an important measure of DES effectiveness.
The Endeavor stent continued to demonstrate excellent safety results for the nearly 700 patients with long-term follow-up, including no observations of late stent thrombosis, which is the formation of dangerous blood clots at least 30 days after implant that can potentially lead to myocardial infarction or death. At 36 months, the combined rate for myocardial infarction, death and TLR - a key clinical measurement called Major Adverse Cardiac Events, or MACE - in the ENDEAVOR I study was 6 percent, while the 24-month MACE rate for ENDEAVOR II was 10 percent. In addition, in the EII study, there was no difference in mortality between the Endeavor (2.1%) arm and the Medtronic DriverŪ (2.2%) bare metal stent arm, and the study also showed a 47 percent reduction in MACE between Endeavor arm (10.0%) and the Driver arm (18.7%).
"The long-term data from these two trials demonstrates a significant and durable treatment effect for patients," said William Wijns, M.D., Co-Principal Investigator for ENDEAVOR II and Co-Director of the Cardiovascular Center, OLV Ziekenhuis, Aalst, Belgium. "The low rate of major adverse cardiac events and the absence of late stent thrombosis provides substantial evidence that the Endeavor drug-eluting stent is safe and provides long-term benefit for patients."
The Endeavor and Driver stents are made of a cobalt alloy and have a unique modular architecture designed to enhance deliverability. In addition to the drug compound zotarolimus (ABT-578), the Endeavor stent is coated with phosphorylcholine (PC), a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane.
"The Endeavor stent was designed to achieve the ideal healing response and these long-term results confirm the outstanding performance of the product" said Scott Ward, president of Medtronic Vascular. "With low rates of restenosis, an unprecedented safety profile and exceptional deliverability, Endeavor is positioned to become the preferred product for patients undergoing angioplasty using drug-eluting stents."
The Medtronic Endeavor clinical program is comprised of five trials, ranging from the first-in-man ENDEAVOR I study to the broad, open-label E-Five registry. At completion, more than 10,000 patients will have been treated with the Endeavor stent. Collectively, more than 3,000 patients in these trials will have been randomized to treatment with either the Endeavor stent, a bare metal stent, or one of two other approved drug-eluting stents.
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 (FDA) in October 2005. The company remains on track for PMA approval in calendar year 2007.
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: The Endeavor Drug-Eluting Coronary Stent is an investigational device with an investigational drug (ABT-578) and exclusively for clinical investigation in the United States.
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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