Healthcare Industry News: STENT Thrombosis
News Release - October 22, 2007
Endeavor Clinical Program Continues to Provide Positive Safety and Efficacy Data
12-Month ENDEAVOR IV Data Delivers Further Safety and Efficacy Evidence for Next-Generation Drug-Eluting StentMINNEAPOLIS--(HSMN NewsFeed)--Building upon the unprecedented wealth of data presented to an Advisory Committee to the U.S. Food and Drug Administration two weeks ago, Medtronic, Inc. (NYSE:MDT ), today presented new 12-month data from the ENDEAVOR IV (E-IV) trial during a main-arena plenary session at the world’s leading scientific congress for interventional cardiologists, TCT 2007 (Transcatheter Cardiovascular Therapeutics), sponsored by the Cardiovascular Research Foundation.
“Significantly, the results at nine months, which contributed to the recent expert panel recommendation on October 10th for FDA approval of the Endeavor stent, were seen again at 12 months,” said Martin B. Leon, MD, Founder and Chairman Emeritus of the Cardiovascular Research Foundation, Professor of Medicine, Columbia University Medical Center (NY), and principal investigator of the ENDEAVOR III and ENDEAVOR IV trials. “ENDEAVOR IV reached its primary endpoint of TVF (target vessel failure) non-inferiority to the Taxus stent. It was very gratifying to learn that the Endeavor had similar efficacy compared to Taxus for all lesion subsets.”
No statistically significant difference in TLR or TVR versus Taxus at 12 months was observed. Endeavor also demonstrated superior procedural success, as measured by the trial protocol. Furthermore, no cases of STENT Thrombosis were reported after six months in the E-IV trial.
Broad clinical performance consistent with preceding clinical evidence
Also reported at TCT was a 12-month, interim analysis of the first 1,989 patients enrolled in ENDEAVOR Five (E-Five), a prospective international registry providing a real-world performance and safety evaluation of the Endeavor stent in markets where it is already commercially available. The primary endpoint of E-Five is MACE (a composite of Major Adverse Cardiac Events) at 12 months.
The interim results of E-Five on nearly 2,000 patients demonstrate further consistency with the preceding clinical trial program. A low rate of MACE (7.0%) was observed, as was a low rate of target lesion revascularization (TLR) of 3.8%. The complete 12-month results on all 8,260 patients will be presented at EuroPCR in May.
Importantly in E-Five, this consistency in performance and safety has also been observed in more complex patients. For E-Five, 34% of the patients had diabetes and 62% had complex lesions. Despite this complexity, the safety profile previously observed is reinforced by these data. Cardiac death was observed at only 2.0%, myocardial infarction at 1.3% and STENT Thrombosis of only 1.1%.
Prepared for full-scale commercial launch
“These results are tremendous, building upon what was already a substantial body of data demonstrating the clinical effectiveness expected from drug-eluting stents but with a safety profile more commonly associated with their bare-metal stent predecessors,” said Scott Ward, president of the CardioVascular business at Medtronic.
“Our data indicate that Endeavor will fill an important and unique gap in vascular therapy, and that many thousands of patients will ultimately benefit from Endeavor’s performance characteristics,” Ward added. “Following the panel’s recommendation we are confident of approval before the end of this calendar year.”
About Medtronic
Medtronic, Inc. (www.medtronic.com), 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. The device is limited by federal (or United States) law to investigational use only.
Any statements made about the anticipated regulatory review or approval are forward-looking statements and subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27. 2007. Actual results may differ materially from anticipated results.
Source: Medtronic
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