Medtronic (NYSE:MDT) today said it launched a clinical trial of its Endurant Evo stent graft for treating abdominal aortic aneurysms.
The 140-patient trial will examine the safety and effectiveness of the Endurant Evo device in patients with infrarenal abdominal aortic or aortoiliac aneurysms, Medtronic said.
The Fridley, Minn.-based medical device colossus said the study’s primary safety endpoint is the proportion of subjects experiencing a major adverse event within 30 days. The secondary endpoint is the proportion of subjects with both technical success at the time of the index procedure and treatment success at 12 months, Medtronic said.
The trial’s results are planned for approval bids in the U.S. and elsewhere, the company said.
Clinical evidence from the study will be used to seek regulatory approvals required to commercialize the Endurant Evo AAA stent graft system in the United States and other markets around the world.
"Medtronic is committed to improving the detection and treatment of aortic disease globally," vice president Daveen Chopra said in prepared remarks. "The Endurant Evo AAA stent graft system provides another proof point for our enduring commitment to invest in innovation for the endovascular treatment of complex aortic disease."