Irish medical technology firm Medtronic has commenced a clinical study of the Endurant Evo AAA stent graft system, in a bid to assess the safety and effectiveness of investigational medical device to treat endovascular abdominal aortic aneurysms.
The system has been designed to expand the applicability of a minimally invasive alternative to open surgical repair for the treatment of abdominal aortic aneurysms.
It is said to be only used in the current clinical study as an investigational medical device, which was approved by the US Food and Drug Administration (FDA) and similar European regulatory bodies.
The study’s two principal investigators Dr Gilbert Upchurch from University of Virginia (UVA) and Dr Hence Verhagen from Rotterdam’s Erasmus Medical Center have carried out the first implant of the low-profile device at the UVA.
Dr Verhagen said: "The Endurant Evo AAA stent graft system has a variety of design features that have the potential to make endovascular repair of abdominal aortic aneurysms an option for more patients."
In the study, the company will enroll up to 140 patients with infrarenal abdominal aortic or aortoiliac aneurysms at up to 30 sites in the US and Europe.
According to the company, the study’s primary effectiveness endpoint is defined as the proportion of subjects with both technical success at the time of the index procedure and treatment success at 12 months post-implantation.
The system features smaller leg diameters and helical limb stents that expand patient applicability in tight distal aortas and tortuous iliac arteries, as well as incorporates an integrated flush port for contrast injection.
Medtronic aortic franchise general manager and vice-president Daveen Chopra said: "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."
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.