Medtronic has started the US post-approval study of the Endurant AAA Stent Graft System to treat abdominal aortic aneurysms (AAA).
The Endurant AAA Stent Graft is a flexible wire frame (stent) sewn onto a specially woven fabric tube (graft) that physicians use to create a new path for blood flow in the patient’s aorta, reducing pressure on the aneurysm and the risk of rupture.
The study is a multicenter, prospective, single-arm designed to assess the long-term safety and effectiveness of the Endurant AAA Stent Graft in a post-market environment.
The study includes approximately 325 subjects across up to 25 US sites.
The primary endpoint is freedom from aneurysm-related mortality at five years after implantation of the stent graft.
Study PI, Harvard Medical School surgery associate professor and Beth Israel Deaconess Medical Center chief of vascular and endovascular surgery Marc Schermerhorn said the resulting data will help clinicians to improve their minimally invasive treatment of patients with abdominal aortic aneurysms.