Device Dossier

Endurant IIs Stent Graft System - Abdominal aortic aneurysm stent

Device Dossier for Endurant IIs Stent Graft System - Abdominal aortic aneurysm stent (Abdominal aortic aneurysm stent, Class III, sponsor Medtronic).…

Intended purpose

The device is a graft system indicated for the endovascular treatment of infrarenal or juxtarenal aortic or aortoiliac aneurysms (with the parallel graft technique) in patients with the following characteristics - adequate iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories; iliac distal fixation length of ≥15 mm; iliac diameters with a range of 8 to 25 mm; morphology suitable for aneurysm repair; one of the following: aneurysm diameter >5 cm or aneurysm diameter of 4 to 5 cm, which has also increased in size by 0.5 cm in the last 6 months or aneurysm that is at least 1.5 times the diameter of the normal infrarenal aorta.

Functional description

The stent graft system when placed within the target lesion, provides a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the lesion from blood flow and pressure. The stent graft is preloaded into the delivery system and advanced to the aneurysm using fluoroscopic guidance. Upon deployment, the stent graft self-expands to conform to the shape and size of the seal zones above and below the aneurysm.

TGA Public Summary