Three-year data for the Endurant Abdominal Aortic Aneurysm stent graft system were presented on 31 May 2013 at the Society for Vascular Surgery’s Vascular Annual Meeting. The data come from the clinical study that contributed to the device’s approval by the FDA in December 2010 and show 100% freedom from aneurysm-related mortality, 0% post-implant aneurysm rupture, 0% stent graft migration and 0% conversion to open repair for the 107 patients followed to three years.
“It is particularly compelling to review this mid-term data on the Endurant system, which delivers sustained clinical performance across key endpoints at three years,” said 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 US 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 US medical centres 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%; and compared to baseline, 95.4% 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.