Ireland-based medical technology firm Medtronic has started a clinical trial of the Endurant Evo AAA stent graft system for the treatment of endovascular abdominal aortic aneurysms (AAA).
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The trial will evaluate the safety and effectiveness of the investigational medical device, which is based on the Endurant platform, in patients with AAA.
The Endurant Evo AAA stent graft system was designed to expand the applicability of a minimally invasive alternative to open surgical repair.
The device features an evolved design that aims to simplify the implant procedure and increase patient customisation options.
The trial’s two principal investigators Dr Gilbert Upchurch from University of Virginia (UVA) and Dr Hence Verhagen from Rotterdam’s Erasmus Medical Center carried out the first implant of the low-profile device at the UVA.
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By GlobalDataDr 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."
A total of 140 patients with infrarenal abdominal aortic or aortoiliac aneurysms will be enrolled in the trial at 30 sites in the US and Europe, and they will be treated with the Endurant Evo AAA stent graft system.
The primary safety endpoint of the trial is defined as the proportion of subjects experiencing a major adverse event within 30 days post-implantation, while its 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.
Data from the trial will be used to seek regulatory approvals required to commercialise the system in the US and other markets worldwide.
The Endurant Evo AAA stent graft 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 vice-president Daveen Chopra said: "Medtronic is committed to improving the detection and treatment of aortic disease globally.
"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: CT reconstruction image of an abdominal aortic aneurysm (white arrows). Photo: courtesy of Bakerstmd.
