Medtronic Starts Clinical Study of Endurant Evo AAA Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysms

Principal Investigators Perform First Implant of Investigational Medical Device Designed to Expand Applicability of Minimally Invasive Alternative to Open Surgical Repair

DUBLIN, Medtronic plc recently began a clinical study to evaluate the safety and effectiveness of the Endurant Evo AAA stent graft system, an investigational medical device designed to expand the applicability of a minimally invasive alternative to open surgical repair for the treatment of abdominal aortic aneurysms.

Based on the market-leading Endurant platform, the Endurant Evo AAA stent graft system features an evolved design that aims to simplify the implant procedure and increase patient customization options.

The study's two principal investigators -- Prof. Gilbert R. Upchurch, Jr., MD, chief of vascular and endovascular surgery at the University of Virginia in Charlottesville, Va., and Prof. Hence Verhagen, MD, PhD, chief of vascular surgery at Erasmus Medical Center in Rotterdam, The Netherlands -- collaboratively performed the first implant of the low-profile device last week at the University of Virginia (UVA). They were assisted by Saher Sabri, MD, an assistant professor from UVA's Division of Interventional Radiology. The patient, a 56-year-old man, had an abdominal aortic aneurysm (AAA) with a 5.05 cm diameter.

"The first clinical use of the Endurant Evo AAA stent graft system went well," said Prof. Upchurch, the study's U.S. principal investigator. "Insertion and deployment were simple and straightforward."

Prof. Verhagen, the study's European principal investigator, added: "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. "That potential is what's most exciting to me about this study."

The study will enroll 140 patients with infrarenal abdominal aortic 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 post-implantation; 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.

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.

The Endurant Evo AAA stent graft system includes the following design features:

• a 3 French reduction in profile facilitates vascular access
• in-situ sizing with a three-piece system and adjustable limb length simplifies pre-case planning and reduces inventory
• an enhanced delivery system eliminates the tip-recapture step and incorporates an integrated flush port for contrast injection
• smaller leg diameters and helical limb stents expand patient applicability in tight distal aortas and tortuous iliac arteries
• multiple aortic body lengths and a larger range of limb lengths and diameters improve patient customization

"Medtronic is committed to improving the detection and treatment of aortic disease globally," said Daveen Chopra, vice president and general manager of the Aortic franchise at Medtronic. "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."

As an investigational medical device, the Endurant Evo AAA stent graft system may only be used in the current clinical study, which has been approved by the U.S Food and Drug Administration (FDA) and similar European regulatory bodies.

Medtronic is the long-standing leader in medical technology for endovascular aortic repair. Medtronic stent grafts have been used to treat more than 400,000 patients worldwide since 1999 -- more than those from any other company. Nearly one of every two stent grafts used to treat an abdominal aortic aneurysm is made by Medtronic.

Source: Medtronic plc