August 31, 2011 — Medtronic Inc. announced the start of its United States post-approval study of the Endurant AAA stent graft system, a medical device used to treat abdominal aortic aneurysms (AAA).
The first patient in the Post-Approval Study Evaluating the Long-Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS) was enrolled earlier this month at Parkwest Medical Center in Knoxville, Tenn. The site’s principal investigator (PI), vascular surgeon Christopher Pollock, M.D., enrolled the patient.
The national PI is Marc Schermerhorn, M.D., chief of vascular and endovascular surgery at Beth Israel Deaconess Medical Center and associate professor of surgery at Harvard Medical School in Boston.
“The ENGAGE clinical program exemplifies Medtronic’s commitment to characterize the real-world, long-term performance of the Endurant AAA Stent Graft,” Schermerhorn said. “The resulting data will help clinicians worldwide improve their minimally invasive treatment of patients with abdominal aortic aneurysms.”
ENGAGE PAS is a prospective, multi-center, single-arm study designed to demonstrate the long-term safety and effectiveness of the Endurant AAA stent graft in a post-market environment. The study will involve approximately 325 subjects and up to 25 United States sites. The primary endpoint of ENGAGE PAS is freedom from aneurysm-related mortality at five years after implantation of the stent graft.
The study augments Medtronic’s international ENGAGE Registry, the largest real-world collection of clinical data on a single stent graft ever compiled. 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 system will be followed out to five years as part of Medtronic’s global clinical program for the device. The program includes company-sponsored pre- and post-market studies conducted worldwide since November 2007, when the first-in-human implant was performed in the Netherlands.
The U.S. Food and Drug Administration (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 United States. It is the market-leading stent graft worldwide.
The Endurant is a flexible wire frame (stent) sewn onto a specially woven fabric tube (graft) physicians use to create a new path for blood flow in the patient’s aorta; this reduces pressure on the aneurysm and the risk of rupture. Delivered through catheters inserted into blood vessels in the groin, the device conforms to a broad range of aortic anatomies; this enables physicians to offer endovascular aortic repair (EVAR) to more AAA patients than ever before.
In the United States, the system is indicated for the endovascular treatment of infrarenal abdominal aortic and aorto-iliac aneurysms in patients with specific anatomical characteristics; these include adequate femoral or iliac artery access, proximal neck length at least 10 mm, infrarenal neck angulation no greater than 60 degrees, and aortic neck diameter of 19 to 32 mm.
For more information: www.medtronic.com