Oria Zenith

FDA-Cleared Indications

• Endovascular repair of thoracoabdominal aortic aneurysms, as described in the available FDA summary.

Clinical Applications

• Endovascular placement across a thoracoabdominal aortic aneurysm to exclude the aneurysm from blood flow.
• Treatment of selected complex thoracoabdominal aortic aneurysms when anatomy is suitable for stent-graft repair.
• Use as a minimally invasive alternative to open surgical aneurysm repair in appropriately selected patients.

Reported off-label uses

• Use in selected aneurysms or dissections outside the specific labeled thoracoabdominal indication has been described for some aortic stent-graft systems, but this should not be assumed to be cleared for the Oria Zenith.

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

• The available record does not provide the device's full size range, delivery-system specifications, or detailed anatomic requirements; clinicians should consult the official labeling.
• Treatment requires suitable aortic landing zones, access vessels, and branch-vessel anatomy, which are assessed with contrast-enhanced CT angiography or another appropriate imaging study.
• Placement is performed under fluoroscopic imaging, usually through femoral or iliac arterial access, with anesthesia or sedation selected according to the procedure and patient.
• MRI safety and conditional scanning requirements must be confirmed from the device labeling; do not assume the graft is safe under all MRI conditions.
• Potential issues include endoleak, graft migration or obstruction, branch-vessel compromise, access-site injury, renal injury from contrast, and the need for lifelong imaging surveillance.