The FDA approved on 21 December 2010 the Endurant abdominal aortic aneurysm stent graft system from Medtronic.
“With FDA approval of Medtronic’s Endurant stent graft, US physicians now have access to a new-generation device that will allow safe treatment of even more complex abdominal arotic aneurysm patients with EVAR than was feasible with previous devices,” said Michel Makaroun, professor and chief of vascular surgery at the University of Pittsburgh Medical Center, and the principal investigator for the US clinical study. “With its innovative design and delivery system, the Endurant stent graft represents another significant advance that expands our toolkit for the minimally invasive management of this dangerous, often deadly, condition.”
In the study, which supported the device’s FDA approval, there were no post-implant aneurysm ruptures or aneurysm-related deaths through one year of patient follow-up, and no patients experienced enlargement of their aneurysms (all remained stable or shrank in size) during this timeframe. Also through one year, there were no device migrations or device-related endoleaks, which can result in persistent blood flow into the aneurysm sac and enlargement of the aneurysm. The study involved 150 patients and 26 medical centres, and successfully met its primary goals and endpoints for assessing the safety and effectiveness of the Endurant stent graft.
“Offering great therapeutic solutions to the highly skilled clinicians who treat patients with aortic disease is the foundation of our leadership in EVAR,” said Tony Semedo, vice president and general manager of Medtronic’s Endovascular Innovations business. “In addition to a portfolio of market-leading stent grafts, Medtronic offers a suite of ancillary products and support services that spans the continuum of care for patients with aortic disease. Our leadership also extends to advocacy for screening, diagnosis and management of this highly treatable condition.”