Device Dossier

Zenith Universal Distal Body Endovascular Graft - Abdominal aortic aneurysm stent

Device Dossier for Zenith Universal Distal Body Endovascular Graft - Abdominal aortic aneurysm stent (Abdominal aortic aneurysm stent, Class III, sponsor…

Intended purpose

The Zenith Universal Distal Body Endovascular Graft is intended to be a component of an intravascular conduit that excludes an aortic aneurysm from blood flow while maintaining distal perfusion.

Functional description

The Zenith Universal Distal Body implant is a bifurcated endovascular graft with one long ipsilateral iliac limb and one short contralateral iliac limb. It is intended to work as a modular system in combination with other Zenith proximal devices and iliac leg grafts. The graft is shipped loaded onto the H&L-B One-Shot Introduction System. It has a sequential deployment method with built-in features to provide continuous control of the graft throughout the deployment procedure.

TGA Public Summary