Medtronic's Endurant II AAA Stent Graft System Approved and Launched in Europe

January 17, 2012—Medtronic, Inc. (Minneapolis, MN) announced the receipt of CE Mark approval and the international launch of the Endurant II abdominal aortic aneurysm (AAA) stent graft system for endovascular aneurysm repair (EVAR). The device is now available in most European countries.
 

In countries where the Endurant II stent graft is approved with the CE mark, the device is indicated for the endovascular treatment of AAA in patients with a proximal neck > 10 mm in length with < 60° infrarenal and < 45° suprarenal angulation and in patients with a proximal aortic neck > 15 mm in length with < 75° infrarenal and < 60° suprarenal angulation.

According to Medtronic, the Endurant II AAA stent graft system offers three enhancements compared with the original Endurant stent graft platform. First, beginning at the point of access, the new lower-profile delivery system—with 35% extended hydrophilic coating for enhanced access to challenging anatomies—allows the 28-mm-diameter bifurcated segment to fit inside an 18-F (outer diameter) catheter compared to 20 F with the original device. Second, the addition of two new contralateral limb lengths (156 and 199 mm) enables more configuration options, requiring fewer total pieces. And third, the radiopacity of the distal end of the bifurcated segment's contralateral gate has been improved to enhance visibility and aid with limb insertion, placement, and deployment.

Medtronic advised that the Endurant II AAA stent graft system is expected to receive approval from the US Food and Drug Administration during 2012. The original Endurant system was approved in the United States in December 2010.


“The Endurant II AAA stent graft system will confer considerable confidence to vascular surgeons who use EVAR to treat even the most complex AAAs,” commented Prof. Hence J. M. Verhagen, MD, who led the European clinical trial of the original Endurant stent graft. “Building on the exceptional clinical outcomes of the original system, which has significantly increased the applicability of EVAR, Endurant II offers an even better user experience, which will benefit even more patients whose AAAs are detected before rupturing.”