Medtronic has started its U.S. post-approval study of the Endurant AAA Stent Graft System, which is used to treat abdominal aortic aneurysms (AAA).
ENGAGE PAS (Evaluating the Long-Term Safety and Effectiveness of the Endurant Stent Graft System) is a prospective, multicenter, single-arm study designed to demonstrate the long-term safety and effectiveness of the Endurant AAA Stent Graft in a post-market environment, Minneapolis-based Medtronic said in a statement. The study will involve approximately 325 subjects and up to 25 U.S. sites. The primary endpoint of ENGAGE PAS is freedom from aneurysm-related mortality at five years after implantation of the stent graft.
Medtronic also maintains the international ENGAGE Registry, a collection of clinical data on the stent graft. Completed in April, the registry enrolled 1,266 patients over two years at 79 sites across 29 countries.
In total, more than 1,800 patients treated with the Endurant AAA Stent Graft System will be followed out to five years as part of Medtronic’s global clinical program for the device.
The Endurant AAA Stent Graft is a stent sewn onto graft that physicians use to create a new path for blood flow in the patient’s aorta.
In the U.S., the Endurant AAA Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic and aorto-iliac aneurysms in patients with specific anatomical characteristics, including adequate femoral or iliac artery access, proximal neck length of at least 10 mm, infrarenal neck angulation of no greater than 60 degrees and aortic neck diameter of 19 mm to 32 mm.
The FDA approved the Endurant AAA Stent Graft System in December 2010. Since then, the device has been used to treat more than 6,000 patients in the U.S.