Device Dossier

Zenith TX2 TAA Endovascular Graft with Pro-Form and Z-Trak Plus Introduction System - Graft, vascular, synthetic

Device Dossier for Zenith TX2 TAA Endovascular Graft with Pro-Form and Z-Trak Plus Introduction System - Graft, vascular, synthetic (Graft, vascular,…

Intended purpose

Intended for treatment of patients with atherosclerotic aneurysms, symptomatic acute or chronic dissections, contained ruptures, growing aneurysms and/or resulting in distal ischaemia, in the descending thoracic aorta having vascular morphology suitable for endovascular repair.

Functional description

A two-piece cylindrical endovascular graft consisting of proximal & distal components, constructed of woven polyester sewn to self-expanding z-stents. Fully stented to provide stability and the expansile force to open the lumen of the graft during deployment. Z-Stents also provide attachment/seal of the graft to the vessel wall. Barbs used for added fixation. Radiopaque gold markers facilitate fluoroscopic visualisation. Shipped preloaded onto either a 20Fr or 22Fr Z-Trak Plus intro. system.

TGA Public Summary