Medtronic Post-Approval Study is Underway

Medtronic Inc. has started its U.S. 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 company’s 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., by the site’s principal investigator, Christopher Pollock, 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 prospective, multi-center, single-arm study will enroll about 325 subjects and up to 25 U.S. sites, and has a primary endpoint of freedom from aneurysm-related mortality at five years after implantation of the stent graft.

The study augments Medtronic’s international ENGAGE registry, which was 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 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.

“From evidence comes confidence,” said Tony Semedo, vice president and general manager of the Endovascular Innovations business for Minneapolis, Minn-based Medtronic. “The ENGAGE clinical program has produced a body of evidence on the Endurant AAA Stent Graft System that engenders confidence among physicians performing endovascular aneurysm repair. It stems from an enduring commitment to advancing the standard of care for AAA with innovative technology that reliably and predictably performs its intended function. We believe ENGAGE PAS, the U.S. post-approval study for our next-generation stent graft, will add to this unmatched dataset.”

The system was approved by the U.S. Food and Drug Administration in December 2010, and since has been used to treat more than 6,000 patients in the United States and become the market-leading stent graft worldwide.

The system consists of 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. Delivered through catheters inserted into blood vessels in the groin, the device conforms to a broad range of aortic anatomies, enabling physicians to offer endovascular aneurysm repair to more patients with AAA.
It is indicated for the endovascular treatment of infrarenal abdominal aortic and aorto-iliac aneurysms in patients with specific anatomical characteristics in the United States. The characteristics include 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.