The Zenith Dissection Endovascular Stent with the the Z-Trak Plus Introduction System is indicated for the endovascular treatment of patients with symptomatic aortic dissection distal to the left subclavian artery (can be used to provide support to delaminated segments of the aorta typical in dissection) having vascular morphology suitable for endovascular repair, including:
• Adequate iliac/femoral access compatible with the required introduction systems; when used together with the Zenith TX2 Dissection Endovascular Graft with Pro-Form.
• Radius of curvature greater than 35 mm along the entire length of aorta intended to be treated by the Zenith Dissection Endovascular Stent,
• Localized angulation less than 45 degrees, and
• Diameter at intended implant site (measured outer wall to outer wall) of no greater than 38 mm (true lumen) and no less than 20 mm (total aortic diameter).
The Zenith Dissection Endovascular Stent is intended to be used as a distal component to a Zenith TX2 Dissection Endovascular Graft with Pro-Form Straight Component or tapered Component, to provide support to delaminated segments of aortic dissection distal to the left subclavian artery. Standard techniques for placement of the descending thoracic aortal access sheaths, guiding catheters, angiographic catheters and wire guides should be employed during use of the Zenith Dissection Endovascular Stent with the Z-Trak Plus Introduction System.