Medtronic Begins Stent Graft System Clinical Trial
Medtronic has initiated a clinical study to evaluate the efficacy of the Endurant Evo abdominal aortic aneurysm treatment stent graft system, the Ireland-based devicemaker announced Monday. The company conducted the first implant of the device last week.
The system consists of small leg diameters and helical limb stents that provide access to tight distal aortas and tortuous iliac arteries.
The multicenter clinical trial will enroll 140 infrarenal abdominal or aortoiliac aneurysm patients at up to 30 sites in the U.S. and Europe. The study’s primary safety endpoint has been designated as the proportion of patients experiencing a major adverse event within 30 days of implantation. Its primary effectiveness endpoint has been designated as the proportion of patients with both technical success at the time of index procedure and treatment success following 12 months of implantation.
The FDA has designated the device for investigational use only.
AAA results from an aortic localized bulge which can expand and rupture, causing extensive internal bleeding that usually ends in death. The disease claims an estimated 15,000 deaths each year in the U.S. — Jason Scott