Medtronic, Inc. is trumpeting with new data on its Endurant AAA stent graft, which it says demonstrates durable clinical performance through three years of patient follow-up in the endovascular repair of Abdominal Aortic Aneurysms.
Medtronic says 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 Mark in July 2008 and the next-generation Endurant II system is now available in more than 100 countries around the world
The data, presented at last week’s Vascular Annual Meeting in San Francisco, comes from the clinical study that contributed to the device’s approval by the U.S. FDA back in 2010. Data now extends to 3 years and shows 100 percent freedom from aneurysm-related mortality, zero percent post-implant aneurysm rupture, zero percent stent graft migration and zero percent conversion to open repair for the 107 patients followed to three years.
The IDE 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.
“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.”
Source: Medtronic, Inc.