Zenith TX2 Thoracic Taa Endovascular Graft with the H Lb One-Shot Introduction System

FDA-Cleared Indications

• Endovascular treatment of aneurysms or ulcers of the descending thoracic aorta in patients with anatomy suitable for endovascular repair.
• Adequate iliac and femoral access compatible with the required introduction system.
• Non-aneurysmal aortic fixation zones proximal and distal to the aneurysm or ulcer that are each at least 25 mm long.
• Proximal and distal fixation zones with an outer-wall-to-outer-wall diameter of 24 to 38 mm.

Clinical Applications

• Endovascular repair of a descending thoracic aortic aneurysm.
• Endovascular treatment of a descending thoracic aortic ulcer.
• Exclusion of diseased thoracic aortic segments using a covered endovascular stent graft.
• Treatment of eligible patients with suitable proximal and distal landing zones and adequate iliac or femoral access.

Reported off-label uses

• Thoracic endovascular aortic repair for selected aortic dissection, traumatic aortic injury, or other thoracic aortic pathology has been reported for thoracic endovascular stent grafts, but these applications are outside the device's stated FDA indication and require individualized specialist assessment.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• Pre-procedure CT angiography is used to assess the aneurysm or ulcer, aortic diameters, proximal and distal landing-zone lengths, vessel tortuosity, and iliac or femoral access.
• The labeled fixation zones must be 24 to 38 mm in diameter and at least 25 mm long; the selected graft size and configuration must match the patient's anatomy and the available system sizes.
• The graft is introduced through the iliac or femoral artery using the H&LB One-Shot Introduction System and deployed under fluoroscopic imaging, usually with anesthesia or monitored sedation.
• Important risks include access-site injury, bleeding, endoleak, graft migration or collapse, aortic injury, stroke, spinal cord ischemia, kidney injury, infection, and the need for reintervention.
• MRI conditions depend on the specific graft model, components, and labeling. The current device-specific instructions for use should be checked before MRI; lifelong imaging surveillance is generally required after thoracic endovascular repair.