Healthcare Industry News: abdominal aortic aneurysm
News Release - June 8, 2007
Medtronic Presents 12-Month Results from VALOR Clinical Study Evaluating Talent(TM) Thoracic Stent GraftMINNEAPOLIS--(HSMN NewsFeed)--Dr. Ronald M. Fairman, principal investigator for the VALOR clinical study evaluating the Talent(TM) Thoracic Stent Graft System, today presented positive 12-month results at a late-breaking session during the annual meeting of the Society for Vascular Surgery in Baltimore. Sponsored by Medtronic (NYSE:MDT ), VALOR is a prospective, multi-center study of 195 test group patients with thoracic aortic aneurysms who were considered candidates for open surgical repair. The primary endpoint is "all cause" mortality at 12 months, comparing minimally invasive endovascular stent graft treatment to a historical surgical control group.
Dr. Fairman reported that patients in the test group who received the Talent Thoracic Stent Graft had a statistically significant reduction in all-cause mortality - 16.1% compared to the surgical control rate of 29.8% (p= less than0.001) - using literature-derived figures for the open surgery group. Aneurysm-related mortality in the VALOR trial was 3.1% at 12 months. The Talent Thoracic system also had a successful aneurysm treatment rate of 89.2%. This was defined as no aneurysm growth greater than 5 mm between 1 and 12 months and the absence of a Type I endoleak.
In addition, the Talent Thoracic Stent Graft system demonstrated 100% patency, which is a measure of the graft's ability to resist collapse and remain open for proper blood flow, and there was a 99.5% success rate in deploying the stent graft. Also, the stent graft system used in the study was available in diameters ranging from 22 mm to 46 mm. Without this wide range of sizes, approximately 25% of the test arm patients in the VALOR trial would not have had the minimally-invasive stent graft therapy available to them as a treatment alternative.
"These results are excellent and demonstrate that the Talent Thoracic Stent Graft provides substantial reductions in all-cause mortality compared to open surgery for this patient population," said Dr. Fairman, chief of the Division of Vascular Surgery, University of Pennsylvania Health System. "For patients who are considered candidates for open surgery, this minimally-invasive method may provide a potential treatment option."
Based on the VALOR data, Medtronic submitted its pre-market approval application to the U.S. Food and Drug Administration in March 2007. The device is awaiting approval. The Talent Thoracic system has been available outside the United States since 1998, with more than 20,000 implants.
"Each year tens of thousands of people in the U.S. are diagnosed with life-threatening thoracic aneurysms or traumas to the aorta," said Katie Szyman, vice president of Medtronic's Endovascular business. "For many, it is difficult for them to undergo and survive open surgery because of other serious medical conditions such as coronary artery disease, high blood pressure or diabetes. Also, open surgery is a complex and risky procedure for many elderly patients. Having a minimally-invasive procedure is an excellent alterative for patients and provides physicians with a choice of treatments."
Medtronic is an international leader in endovascular therapies and currently markets several of the world's leading stent grafts, including the AneuRx® AAAdvantage Stent Graft System for abdominal aortic aneurysms (AAA) in the United States, and the Talent AAA and Valiant Thoracic Stent Graft Systems outside the United States.
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.
Editors: VALOR = Evaluation of the Medtronic Vascular TALent Thoracic Stent Graft System for the Treatment of ThORacic Aortic Aneurysms
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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