Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
Endurant: Medtronic announces May 6 it has completed enrolling patients in a clinical trial of its Endurant endovascular abdominal aortic aneurysm (AAA) stent graft two months ahead of schedule. The single-arm trial is intended to support a PMA for non-surgical AAA repair. The company expects to announce key data from the study in late 2010. The study enrolled about 150 patients at 30 centers. The primary endpoint is one-year treatment success. Medtronic is also sponsoring the Endurant Stent Graft Natural Selection Global Post-market (ENGAGE) registry, evaluating Endurant in about 1,200 patients at 80 centers on six continents (1"The Gray Sheet" April 13, 2009, p. 15)