Medtronic Begins US Postapproval Study of Endurant AAA Stent Graft

August 31, 2011—Medtronic, Inc. (Minneapolis, MN) announced the start of ENGAGE PAS, its US postapproval study of the Endurant AAA stent graft system for the treatment of abdominal aortic aneurysms (AAA). The US Food and Drug Administration approved the Endurant AAA stent graft system in December 2010.



According to Medtronic, ENGAGE PAS is a prospective, multicenter, single-arm study designed to demonstrate the long-term safety and effectiveness of the Endurant AAA stent graft in a postmarket environment. The study will involve approximately 325 patients at up to 25 sites in the United States. The primary endpoint of ENGAGE PAS is freedom from aneurysm-related mortality at 5 years after implantation of the stent graft. The study's national principal investigator is Marc Schermerhorn, MD. 



The company stated that the United States study augments Medtronic's international ENGAGE registry, which was completed in April. The registry enrolled 1,266 patients in 2 years at 79 sites in 29 countries. In total, more than 1,800 patients treated with the Endurant AAA stent graft system will be followed out to 5 years as part of Medtronic's global clinical program for the device. The program includes company-sponsored pre- and postmarket studies conducted worldwide since November 2007.



Medtronic advised that in the United States, the Endurant AAA stent graft system is indicated for the endovascular treatment of infrarenal abdominal aortic and aortoiliac aneurysms in patients with specific anatomical characteristics, including adequate femoral or iliac artery access, proximal neck length > 10 mm, infrarenal neck angulation ≤ 60º, and aortic neck diameter of 19 to 32 mm.