Study Begins for Medtronic's Endurant Evo AAA Stent Graft System

April 27, 2015—Medtronic plc recently began a clinical study to evaluate the safety and effectiveness of the Endurant Evo abdominal aortic aneurysm (AAA) endovascular stent graft system. 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.

According to Medtronic, the study will enroll 140 patients with infrarenal AAAs or aortoiliac aneurysms at up to 30 sites in the United States and Europe. All study patients will be treated with the Endurant Evo AAA stent graft system.

The study’s primary safety endpoint is defined as the proportion of subjects experiencing a major adverse event within 30 days postimplantation. The 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 postimplantation.

Prof. Gilbert R. Upchurch, Jr, MD, serves as the study’s Principal Investigator in the United States. The European Principal Investigator is Prof. Hence Verhagen, MD. Prof. Upchurch is Chief of Vascular and Endovascular Surgery at the University of Virginia (UVA) in Charlottesville, Virginia. Prof. Verhagen is Chief of Vascular Surgery at Erasmus Medical Center in Rotterdam, The Netherlands.

Profs. Upchurch and Verhagen collaboratively performed the first implantation of the low-profile device at UVA, assisted by Saher Sabri, MD, an Assistant Professor with UVA’s Division of Interventional Radiology. The patient was a 56-year-old man who had a AAA that was 5.05 cm in diameter.

In Medtronic’s press release, Prof. Upchurch commented, “The first clinical use of the Endurant Evo AAA stent graft system went well. Insertion and deployment were simple and straightforward.”

Prof. Verhagen added, “The Endurant Evo AAA stent graft system has a variety of design features that have the potential to make endovascular repair of AAAs an option for more patients. That potential is what's most exciting to me about this study.”

Daveen Chopra, Vice President and General Manager of the aortic franchise at Medtronic, commented in the company’s press release, “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.”

The Endurant Evo AAA stent graft system, which is based on the company’s Endurant platform, is designed to simplify the implantation procedure and increase patient customization options. The device features the following: a 3-F reduction in profile facilitates vascular access, in situ sizing with a three-piece system and adjustable limb length that simplifies case planning and reduces inventory, an enhanced delivery system that eliminates the tip-recapture step and incorporates an integrated flush port for contrast injection, smaller leg diameters and helical limb stents that expand patient applicability in tight distal aortas and tortuous iliac arteries, and multiple aortic body lengths with a larger range of limb lengths and diameters to improve patient customization.

The Endurant Evo AAA stent graft system is an investigational device that may only be used in the current clinical study, which has been approved by the US Food and Drug Administration and similar European regulatory bodies, advised Medtronic.