Medtronic begins clinical trial of Endurant Evo AAA stent graft system

Ireland-based clinical technology firm Medtronic has started a clinical trial of the Endurant Evo AAA stent graft system for the treatment of abdominal aortic stent graft system.

The trial will evaluate the safety and effectiveness of the investigational clinical gadget, which depends on the Endurant platform, in patients with AAA.
 
The Endurant Evo AAA stent graft system was intended to expand the applicability of a minimally invasive alternative to open surgical fix.

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The gadget features an advanced plan that intends to improve on the implant methodology and increase patient customisation options.
 
The trial's two principal investigators Dr Gilbert Upchurch from University of Virginia (UVA) and Dr Subsequently Verhagen from Rotterdam's Erasmus Clinical Center completed the first implant of the position of safety gadget at the UVA.
 
"The gadget features an advanced plan that means to improve on the implant methodology and increase patient customisation options."
Dr Verhagen said: "The Endurant Evo AAA stent graft system has a variety of configuration features that can possibly make endovascular fix of abdominal aortic aneurysms an option for additional patients."
 
A total of 140 patients with infrarenal abdominal aortic or aortoiliac aneurysms will be signed up for the trial at 30 sites in the US and Europe, and they will be treated with the Endurant Evo AAA stent graft system.
 
The essential safety endpoint of the trial is defined as the proportion of subjects experiencing a significant unfavorable event within 30 days post-implantation, while its essential effectiveness endpoint is defined as the proportion of subjects with both technical accomplishment at the time of the index method and treatment accomplishment at 12 months post-implantation.
 
Data from the trial will be utilized to look for regulatory endorsements expected to popularize the system in the US and other markets around the world.
 
The Endurant Evo AAA stent graft system features more modest leg diameters and helical appendage 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 establishment VP Daveen Chopra said: "Medtronic is committed to improving the detection and treatment of aortic sickness universally.
 
"The Endurant Evo AAA stent graft system gives another evidence point to our enduring commitment to invest in innovation for the endovascular treatment of perplexing aortic sickness."

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