|Endurant AAA Stent Graft Delivers Durable Outcomes for Abdominal Aortic Aneurysm Repair|
Three-Year Clinical Data Presented at Annual Meeting of Society for Vascular Surgery Reaffirms Physician Confidence in Market-Leading Endovascular Device
SAN FRANCISCO -- May 31, 2013 -- The Endurant AAA stent graft system from Medtronic, Inc. (NYSE: MDT) continues to distinguish itself, with new data on the market-leading device for the endovascular repair of abdominal aortic aneurysms demonstrating durable clinical performance through three years of patient follow-up.
Presented at the Society for Vascular Surgery's "Vascular Annual Meeting," the three-year data comes from the clinical study that contributed to the device's approval by the U.S. Food and Drug Administration (FDA) in Dec. 2010. The data show 100 percent freedom from aneurysm-related mortality, 0 percent post-implant aneurysm rupture, 0 percent stent graft migration and 0 percent conversion to open repair for the 107 patients followed to three years.
"It's particularly compelling to review this mid-term data on the Endurant system, which delivers sustained clinical performance across key endpoints at three years," said Dr. William Jordan Jr., professor of surgery and chief of vascular surgery and endovascular therapy at the University of Alabama Birmingham. "The robust outcomes seen in the U.S. study confirm the durability of the Endurant stent graft."
Under an investigational device exemption (IDE) granted by the FDA, the study enrolled 150 patients at 26 U.S. medical centers and continues to chart the Endurant stent graft's strong performance in the endovascular repair of abdominal aortic aneurysms. The rate of freedom from secondary endovascular procedures to the three-year time-point was 91.5 percent; and compared to baseline, 95.4 percent of the aneurysm sacs were either the same size or had decreased in diameter by at least 5mm at three years. Only one patient in the study had a Type I/III endoleak at three years.
Chosen for nearly one out of every two endovascular abdominal aortic aneurysm repairs worldwide, the Endurant system has been used to treat more than 100,000 patients, a milestone achieved in the spring of 2013-less than five years after the device's initial launch: the original Endurant AAA stent graft received the CE (Conformité Européene) Mark in July 2008. The next-generation Endurant II system is now available in more than 100 countries around the world
In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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