Interventional device developer Medtronic has begun a U.S. postapproval study of its Endurant abdominal aortic aneurysm (AAA) stent graft system.
The prospective, multicenter, single-arm study -- called Postapproval Study Evaluating the Long-Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS) -- is designed to demonstrate the long-term safety and effectiveness of the Endurant AAA stent graft in a postmarket environment. It will include approximately 325 subjects and up to 25 U.S. sites, according to the vendor.
Medtronic said the primary end point of the study will be freedom from aneurysm-related mortality at five years after implantation of the stent graft. The first patient was enrolled earlier this month at Parkwest Medical Center in Knoxville, TN, by the site's principal investigator, vascular surgeon Dr. Christopher Pollock.
