The Endurant II/IIs stent graft system is indicated for the endovascular treatment of infrarenal or juxtarenal abdominal aortic or aortoiliac aneurysms 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
- aneurysm diameter of 4 to 5 cm, which has also increased in size by 0.5 cm in the last 6 months
- aneurysm that is at least 1.5 times the diameter of the normal infrarenal aorta
In addition, for treatment of infrarenal abdominal aortic or aortoiliac aneurysms, the following patient characteristics apply:
- aortic neck diameters with a range of 19 to 32 mm
- proximal neck length of ≥10 mm or ≥4 mm and <10 mm when used in conjunction with the Heli-FX EndoAnchor system, with insignificant calcification, or insignificant thrombus with ≤60° infrarenal and ≤45° suprarenal angulation and a vessel diameter approximately 10% to 20% smaller than the labelled Endurant II/Endurant IIs stent graft diameter
- proximal neck length of ≥15 mm with insignificant calcification, or insignificant thrombus with ≤75° infrarenal and ≤60° suprarenal angulation and a vessel diameter approximately 10% to 20% smaller than the labelled Endurant II/Endurant IIs stent graft diameter
In addition, for treatment of juxtarenal abdominal aortic or aortoiliac aneurysms with the parallel graft technique, the following patient characteristics apply:
- aortic neck diameters with a range of 19 mm to 30 mm
- infrarenal proximal neck length of ≥2 mm and total available proximal seal length >15 mm with a balloon expandable covered stent deployed in a parallel graft technique in one or two renal arteries and with insignificant calcification, or insignificant thrombus with ≤60° infrarenal, ≤45° suprarenal, and ≤45° suprasuperior mesenteric artery angulation (supraSMA angulation) and an aortic diameter approximately 20% to 30% smaller than the labelled Endurant II/Endurant IIs stent graft diameter
- adequate brachial or axillary access that is compatible with vascular access techniques, devices, or accessories
- sufficient renal fixation length
- renal take off angulation <90° relative to the aortic centerline
Note: The angle between the aortic and renal artery blood lumen centerlines is the renal take-off angulation. An angle of <90° is associated with a downward-pointed renal artery relative to the trajectory of the aortic centerline.