Device Dossier

Endurant II Stent Graft System - Limb - Abdominal aortic aneurysm stent

Device Dossier for Endurant II Stent Graft System - Limb - Abdominal aortic aneurysm stent (Abdominal aortic aneurysm stent, Class III, sponsor…

Intended purpose

The intended use of the Endurant II stent graft system is to repair infrarenal abdominal aortic or aortoiliac aneurysms, or juxtarenal abdominal aortic or aortoiliac aneurysms (with a parallel graft technique), in an endovascular approach by providing an alternative conduit for blood flow within the patient’s vessel (aorta and iliac arteries) by excluding the aneurysm (target lesion).

Functional description

The Endurant II Stent Graft System is comprised of the Endurant II Stent Graft and the Endurant II Delivery System. The stent graft is compressed and held constrained on the delivery system as it is advanced to the aneurysm location over a guidewire. As deployment occurs , the graft self expands to cover the aneurysm.

TGA Public Summary