Device Dossier

Endurant IIs Stent Graft System - Bifurcated Stent Graft - Abdominal aortic aneurysm stent

Device Dossier for Endurant IIs Stent Graft System - Bifurcated Stent Graft - Abdominal aortic aneurysm stent (Abdominal aortic aneurysm stent, Class…

Intended purpose

The intended use of the Endurant IIs 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 IIs 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. Endurant IIs Bifurcated Stent Graft is an aortic stent graft, it is a bifurcated stent.

TGA Public Summary