Gore Excluder Conformable Aaa Endoprosthesis Excc

FDA-Cleared Indications

• Treatment of abdominal aortic aneurysms using endovascular aneurysm repair.
• Use in patients with aortic anatomy that meets the device's approved anatomic and sizing requirements.
• Implementation of approved changes to manufacturing stations for the delivery system.

Clinical Applications

• Endovascular repair of infrarenal abdominal aortic aneurysms.
• Treatment of selected AAAs with challenging proximal aortic neck anatomy when the anatomy falls within the product labeling.
• Exclusion of an abdominal aortic aneurysm from blood flow using a modular endovascular graft and iliac limb components.
• Treatment of patients considered appropriate for endovascular repair rather than open surgical repair.

Reported off-label uses

• Use outside the manufacturer's specified aortic neck length, diameter, angulation, or iliac access and landing-zone requirements.
• Use in selected juxtarenal or more proximally located aortic aneurysms when standard infrarenal EVAR instructions for use are not met.

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

• Device selection depends on preoperative CT angiography, including aortic neck diameter and length, neck angulation, aneurysm morphology, iliac landing zones, and access-vessel size.
• The system is modular and requires compatible main-body and iliac limb components selected according to the manufacturer's sizing instructions.
• Delivery is performed through femoral or iliac arterial access under fluoroscopic imaging, usually with local anesthesia and sedation or general anesthesia.
• Follow-up imaging is required after EVAR to evaluate graft position, aneurysm sac behavior, limb patency, and possible endoleak or migration.
• MRI conditions, including field strength and specific device configuration, should be confirmed in the current manufacturer labeling before scanning.