Three-Year Clinical Data Presented for Endurant AAA Stent Graft

May 31, 2013—New data on the Endurant abdominal aortic aneurysm (AAA) stent graft system (Medtronic, Inc., Minneapolis, MN) were presented at the Society for Vascular Surgery's Vascular Annual Meeting being held in San Francisco, California. The new data demonstrate durable clinical performance through 3 years of patient follow-up.

The 3-year data come from the clinical study that contributed to the device's approval by the US Food and Drug Administration in December 2010. The data show 100% freedom from aneurysm-related mortality, 0% postimplantation aneurysm rupture, 0% stent graft migration, and 0% conversion to open repair for the 107 patients who were followed to 3 years.

Under an investigational device exemption granted by the US Food and Drug Administration, the study enrolled 150 patients at 26 medical centers in the United States and continues to chart the Endurant stent graft's performance for the endovascular repair of AAAs. The rate of freedom from secondary endovascular procedures to the 3-year time-point was 91.5% compared to baseline, and 95.4% of the aneurysm sacs were either the same size or had decreased in diameter by at least 5 mm at 3 years. Only one patient in the study had a type I/III endoleak at 3 years.

“It's particularly compelling to review this midterm data on the Endurant system, which delivers sustained clinical performance across key endpoints at 3 years,” said Dr. William Jordan Jr, Professor of Surgery and Chief of Vascular Surgery and Endovascular Therapy at the University of Alabama Birmingham, in the company's press release. “The robust outcomes seen in the US study confirm the durability of the Endurant stent graft.”

The original Endurant AAA stent graft received CE Mark approval in July 2008, and the next-generation Endurant II system is now available in more than 100 countries around the world, the company advised.