Zenith® TX2® Dissection Endovascular Graft with Pro-Form® 4 mm Tapered Components

The Zenith Dissection Endovascular System (Zenith TX2 Dissection Endovascular Graft with Pro-Form and Zenith Dissection Endovascular Stent) is indicated for the endovascular treatment of patients with Type B aortic dissection. The Zenith TX2 Dissection Endovascular Graft with Pro-Form is intended to seal the entry tear(s) and to exclude aneurysms associated with chronic dissections. The Zenith Dissection Endovascular Stent is intended to be used as a distal component to provide support to delaminated segments of non-aneurysmal aorta with dissection distal to a Zenith TX2 Dissection Endovascular Graft with Pro-Form. The system is indicated for use in patients having suitable vascular anatomy for endovascular repair, including: 

• Adequate iliac/femoral access compatible with the required introduction systems 

• For the Zenith TX2 Dissection Endovascular Graft with Pro-Form:

     o Non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a length of at least 20 mm,

     o Non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a diameter (measured outer-wall to outer-wall) of no greater than 38 mm and no less than 20 mm, and 

• For the Zenith Dissection Endovascular Stent:

     o Diameter at non-aneurysmal intended implant site for the stent (measured outer-wall to outer-wall) of no greater than 38 mm (true lumen) and no less than 20 mm (total aortic diameter).