Medtronic Launches Endurant II AAA Stent Graft System

June 6, 2012—Medtronic, Inc. (Minneapolis, MN) announced the launch of the Endurant II abdominal aortic aneurysm (AAA) stent graft system in the United States. The device recently received approval from the US Food and Drug Administration (FDA) for the endovascular repair of AAAs. In Europe, the Endurant II AAA stent graft received CE Mark approval in December 2011.

Medtronic will present the Endurant II AAA system at the Society for Vascular Surgery's Vascular Annual Meeting on June 7-9 in National Harbor, Maryland. Clinical performance updates for the device will also be presented at the meeting.

According to Medtronic, FDA approval of the Endurant II is based on the results of the United States clinical study of the predicate device, which continues to demonstrate strong clinical performance and efficacy in long-term follow-up. The outcomes at 2 years showed no type I endoleaks, migration, conversion to surgery, or aneurysm-related mortality. Furthermore, aneurysm sac diameter decreased or remained stable in 98.3% of patients at 2 years.

The company stated that the Endurant II adds three features to the original Endurant device, which received FDA approval in December 2010. The Endurant II enhancements are a lower profile delivery system with an extended hydrophilic coating that improves access so that the mostly commonly used 28-mm diameter stent graft now fits inside an 18-F outer diameter catheter; new contralateral limb lengths of 156 mm and 199 mm; and improved radiopacity of the contralateral gate on the distal end.

William Jordan, MD, Professor and Chief of Vascular Surgery and Endovascular Therapy at the University of Alabama, served as one of the principal investigators for the study of the Endurant II. “The Endurant II stent graft is a very deliverable device that enhances the ability to treat more patients than previous devices and to traverse challenging anatomies, especially iliac arteries with tight access,” commented Dr. Jordan in a company press release. “Considering the exceptional clinical performance of the original system, the Endurant II stent graft is even easier to use in both straightforward and challenging anatomies.”