Zenith Flex System

FDA-Cleared Indications

• The supplied record does not provide the actual FDA-cleared indication statement.
• The existing description states use for endovascular repair of abdominal aortic aneurysms.
• The product code listed, NRY, is identified in the record as a catheter/thrombus-retriever code rather than an abdominal aortic endovascular stent-graft code.

Clinical Applications

• Endovascular aneurysm repair of an abdominal aortic aneurysm when the patient’s anatomy meets the device’s labeled requirements.
• Deployment of a modular stent-graft system within the abdominal aorta and iliac arteries to exclude an aneurysm from circulation.
• Treatment planning with preprocedure CT angiography to assess aortic diameter, landing zones, access vessels, and iliac anatomy.

Reported off-label uses

• Use in anatomies outside the manufacturer’s labeled aortic and iliac dimensions or landing-zone requirements has been reported in clinical practice, but this is off-label and may increase the risk of endoleak, migration, limb occlusion, or other complications.

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

• Confirm the device identity, FDA clearance, product code, and current manufacturer instructions before clinical use; the supplied manufacturer and product-code information appears internally inconsistent.
• Patient selection depends on adequate proximal and distal landing zones, aortic and iliac vessel dimensions, access-vessel size, tortuosity, calcification, and thrombus burden.
• The system is delivered through an arterial access site, commonly the common femoral artery, using fluoroscopic imaging and contrast angiography.
• MRI safety and conditional scanning limits must be checked in the current device labeling; do not assume MRI compatibility from the device name alone.
• Follow-up imaging is required after EVAR to assess graft position, endoleak, aneurysm sac behavior, limb patency, and possible reintervention.