046 Zenith Flex

FDA-Cleared Indications

• Endovascular treatment of aortic aneurysms using a catheter-delivered stent graft.
• Use in patients whose aortic aneurysm anatomy is appropriate for endovascular repair.

Clinical Applications

• Endovascular repair of selected abdominal aortic aneurysms.
• Endovascular repair of selected thoracic aortic aneurysms when the device labeling and anatomy are appropriate.
• Exclusion of an aneurysm from blood flow by creating a graft-lined channel inside the aorta.
• Treatment of patients for whom minimally invasive endovascular repair is selected instead of open surgical repair.

Reported off-label uses

• Use in aortic conditions or anatomic locations outside the device's specific cleared labeling may occur in specialist practice, but this is off-label and requires individualized physician judgment.

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

• Accurate measurement of the aorta, aneurysm, landing zones and access vessels is required for device selection and sizing.
• The device is delivered through a catheter-based system, usually through the femoral or iliac arteries, with fluoroscopic imaging guidance.
• Anatomy that is too small, tortuous, calcified or otherwise unsuitable may prevent safe delivery or sealing.
• MRI safety and scanning conditions must be confirmed in the current manufacturer instructions for use; do not assume compatibility from the product name alone.
• Potential complications include endoleak, graft migration, limb or branch-vessel obstruction, access-site injury, bleeding, infection, kidney injury from contrast, conversion to open surgery and continued aneurysm enlargement or rupture.