Gore Excluder Thoracoabdominal Branch Endoprosthesis

FDA-Cleared Indications

• FDA PMA P230023 approval applies to the manufacture of the endoprosthesis sub-assembly at W. L. Gore & Associates, Inc., 32360 N. North Valley Parkway, Phoenix, Arizona 85085-4228.
• The supplied FDA record does not provide a patient-selection indication or complete clinical-use labeling for the device.

Clinical Applications

• Manufacture of the endoprosthesis sub-assembly at the FDA-approved W. L. Gore & Associates facility.
• The device is designed for endovascular repair of selected thoracoabdominal aortic aneurysms when used according to the complete FDA-approved labeling.

Reported off-label uses

• Use in aortic aneurysm or dissection patterns outside the approved anatomic and patient-selection criteria may occur in specialized practice, but this is off-label and should be evaluated by an experienced aortic team.

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

• Patient selection depends on the aneurysm’s extent, branch-vessel anatomy, landing zones, access vessels, and the sizing requirements in the current instructions for use.
• Preprocedural thin-slice CT angiography is typically required to assess the aorta, visceral branches, iliac access, vessel diameters, tortuosity, and calcification.
• The system includes preloaded guidewires intended to assist cannulation of branch vessels; careful device handling and fluoroscopic imaging are required.
• MRI conditions, including field strength, spatial gradient, specific absorption rate limits, and any waiting period, must be confirmed in the current manufacturer labeling before scanning.
• Contraindications and warnings may include unsuitable anatomy, inability to tolerate anticoagulation or contrast, severe access-vessel limitations, infection, and risks of endovascular aortic repair such as endoleak, branch-vessel occlusion, spinal cord ischemia, renal injury, and the need for reintervention.