Updated May 30, 2013, at 7:30 p.m. to correct that approval was granted for the Endurant II Aorto-Uni-Iliac stent graft system.
Medtronic (NYSE:MDT) said the FDA granted pre-market approval for its Endurant II Aorto-Uni-Iliac stent graft to treat abdominal aortic aneurysms and clearance for the Sentrant introducer sheath used with the AUI device.
The Fridley, Minn.-based device company showed off both devices today at the Society for Vascular Surgery’s annual meeting in San Francisco. They’re designed to be used together during stent grafting procedures for endovascular aortic repair.
The Endurant II AUI won a novel indication as the only FDA-approved device indicated for endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients who do not qualify for a bifurcated device, according to a press release.
"By maintaining the deliverability, conformability and deployment accuracy of the bifurcated Endurant device, the AUI configuration offers aneurysm patients with challenging outflow anatomies a better option for a successful endovascular aortic repair," Dr. Michel Makaroun, chief of cardiovascular surgery at University of Pittsburgh Medical Center, said in a company statement.
Medtronic launched Endurant II in Europe last year and in the U.S. following FDA approval in June 2012. The medtech titan is currently touting positive 2-year trial results for the next-generation Endurant III.
The Sentrant sheath won CE Mark approval last month. It’s a tapered tube that threads through a patient’s iliac artery for easier stent graft placement in the aorta.