Device Dossier

Radiant Balloon Expandable Covered Stent - Abdominal aortic aneurysm stent

Device Dossier for Radiant Balloon Expandable Covered Stent - Abdominal aortic aneurysm stent (Abdominal aortic aneurysm stent, Class III, sponsor…

Intended purpose

The Radiant balloon-expandable covered stent system is intended to maintain perfusion to the renal arteries when used in combination with the Endurant II/IIs stent graft system. The devices are used together to repair juxtarenal abdominal aortic or aortoiliac aneurysms with a parallel graft technique in an endovascular approach. This is accomplished by providing an alternative conduit for blood flow within the patient’s vessel (aorta, iliac, and renal arteries) by excluding the aneurysm (target lesion).

Functional description

The Radiant balloon-expandable covered stent system is indicated for the maintenance of perfusion to the renal arteries when used in conjunction with the Endurant II/IIs stent graft system in the treatment of juxtarenal abdominal aortic or aortoiliac aneurysms with the parallel graft technique.

TGA Public Summary