The Endurant abdominal aortic aneurysm stent graft features a unique design to conform to the vascular anatomy of the patient. The proximal covered M-shaped stent reinforces the radial force on the proximal neck and achieves sealing even in angulated and short necks. Distally, stents of the Endurant limbs are short and positioned to follow curvatures and to avoid kinks in the iliac arteries.
The Endurant delivery system with tip capture mechanism makes the deployment easy, precise and controllable. The four proximal radiopaque markers assist with anterior-posterior view to align the stent graft with respect to the central axis of the aorta lumen.
The Endurant delivery system incorporates a hydrophilic coating and an inner nitinol tube, which improve trackability. More importantly, the profile has been substantially reduced compared to previous generation stent grafts.
Medtronic is committed to evidence-based medicine. A strong clinical programme has been established to generate data about the device and provide additional support to physicians eager to expand the option of endovascular treatment to their patients. Before CE mark, a prospective multicentre trial was undertaken in Europe, which continues to assess one-year safety and performance in 80 patients.
To obtain FDA approval, a prospective multicentre trial has also been initiated in the US to enrol 200 patients. Finally, a postmarket global study is about to be started to generate real-world device performance data with a five-year follow-up period.
The Endurant stent graft system received European CE mark approval in July 2008. Since then, more than 2,000 patients have been treated with the device. The Endurant stent graft system is not commercially available in the US.
