Gore Excluder Aaa Endoprosthesis

FDA-Cleared Indications

• Endovascular treatment of abdominal aortic aneurysms using an endovascular graft system.
• Use in patients whose aortic and iliac anatomy meets the device-specific requirements in the current instructions for use.
• The 2006 FDA record identifies a change to an acceptance criterion for a component used in manufacturing the device; it does not provide a new clinical indication in the supplied FDA text.

Clinical Applications

• Endovascular aneurysm repair of selected infrarenal abdominal aortic aneurysms.
• Treatment of abdominal aortic aneurysms in patients whose proximal aortic neck, aneurysm morphology, and iliac access vessels meet the device labeling.
• Use as a modular endovascular graft system with a main body and iliac limb components to exclude the aneurysm from circulation.
• Repair performed through catheter access, typically through the common femoral arteries, when anatomy is suitable for the labeled device configuration.

Reported off-label uses

• Use outside the device's labeled anatomic requirements, including selected anatomies with inadequate proximal neck or iliac landing zones, has been described in clinical practice but is off-label and may carry additional risks.
• Selected emergency or complex aortic applications outside the original abdominal aortic aneurysm labeling have been reported for endovascular grafts, but require case-specific specialist judgment and are not established indications for this device record.

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 device is modular and available in multiple diameters and lengths; component selection must match the patient's aortic neck, aneurysm, and iliac artery measurements.
• Preprocedure CT angiography is generally used to assess landing zones, vessel diameter, tortuosity, calcification, thrombus, and femoral or iliac access.
• Important contraindications or limitations may include anatomy outside the instructions for use, unsuitable landing zones, inadequate iliac access, active infection, or inability to tolerate contrast, anticoagulation, or the procedure.
• Follow-up imaging is required to monitor for endoleak, graft migration, limb obstruction, aneurysm enlargement, or other late device-related complications.
• MRI safety and scanning conditions depend on the exact GORE EXCLUDER component and labeling for the implanted configuration; the current device-specific MRI conditions should be checked before scanning.