Device Dossier

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

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

Intended purpose

The Endurant II Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. When placed within the aneurysm, the Endurant II Stent Graft provides a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.

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