Engage is expected to enroll 1,200 patients with abdominal aortic aneurysms at up to 80 medical centers across six continents. Patients who meet the single-arm study’s inclusion criteria will be treated with the Endurant system and followed for five years. The study’s primary endpoint is treatment success at 12 months.
Treatment success is a composite endpoint which requires the satisfaction of several criteria. These criteria include successful technical delivery and deployment of the stent graft as well as freedom from: aneurysm swelling; endoleaks; aneurysm rupture; conversion to surgery; graft migration; and graft occlusion.
The Endurant stent graft system is reported to expand Medtronic’s portfolio of aortic repair technologies, which offer physicians a broad array of devices to choose from in treating patients with aortic aneurysms. It received Conformite Europeene mark in July 2008 and is now commercially available in more than 80 countries. Use of the Endurant stent graft system in the US is limited to an investigational clinical trial.
Tony Semedo, vice president of cardiovascular and general manager of the endovascular innovations division at Medtronic, said: “Around half of aortic repair procedures are currently performed using endovascular stent grafts. The Engage study is designed to provide clinicians with enhanced confidence in the performance and ease of use of the Endurant stent graft, so even more patients benefit from a life-saving procedure without the need for open surgery.”