Zenith

FDA-Cleared Indications

• Endovascular repair of aortic aneurysms when the patient's anatomy is suitable for the labeled device.
• Placement of an endovascular graft to exclude an aneurysm from blood flow and reduce pressure on the aneurysm wall.

Clinical Applications

• Endovascular aortic aneurysm repair using a stent-graft.
• Treatment of selected aortic aneurysms through catheter-based graft placement.
• Creation of a supported blood-flow channel through an aneurysmal segment of the aorta.

Reported off-label uses

• Use in selected aortic dissections or penetrating aortic ulcers may be described for related endovascular graft devices, but this should not be assumed to be labeled for this specific record.
• Use outside the labeled aortic anatomy or patient-selection criteria may occur in clinical practice, but requires individualized physician judgment and is not an FDA-cleared indication based on the information provided.

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 diameter, length, limb configuration, delivery-system size, or anatomic sizing range; these details should be confirmed in the current labeling.
• Use requires preprocedure imaging to assess aortic diameter, landing zones, access vessels, tortuosity, and calcification.
• Potential complications include endoleak, graft migration, limb kinking or occlusion, vascular injury, thrombosis, and the need for later reintervention.
• MRI safety and conditional-scanning requirements cannot be determined from this record and should be checked in the device labeling or implant card.
• Contraindications and warnings should be reviewed in the applicable instructions for use, including issues involving infection, unsuitable anatomy, contrast allergy, renal impairment, and inability to tolerate the procedure.