Device Dossier
Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak Plus Introduction System - Graft, vascular, synthetic
Device Dossier for Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak Plus Introduction System - Graft, vascular, synthetic (Graft,…
- GMDN category: Graft, vascular, synthetic
Intended purpose
The Zenith TX2 Dissection Endovascular Stent Graft with Pro-Form and the Z-Trak Plus Introduction System is indicated for the endovascular treatment of patients with symptomatic dissection of the descending thoracic aorta having vascular morphology suitable for endovascular repair, including: a)Adequate Iliac/femoral access compatible with the required introduction systems, b)Radius of curvature greater than 35mm along the length of aorta intended to be treated by Straight or Tapered Component c)Non-dissected/aneurysmal aortic segments (fixation sites)proximal to the entry tear with a length of at least 20mm, a diameter measured outer wall to outer wall of no greater than 38mm and no less than 20mm, and with localised angulation less than 45 degrees
Functional description
The Zenith TX2 Dissection Endovascular Graft is constructed of full-thickness, woven polyester fabric sutured with braided polyester and monofilament polypropylene suture to self-expanding stainless steel Cook-Z stents. The Stent Graft is fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. The introduction system enables precise placement with the ability to readjust the graft befopre full deployment.