Zenith Dissection Endovascular System

FDA-Cleared Indications

• The FDA record identifies a change in the glue-curing time for the tip assemblies of the introduction systems used with the Zenith Alpha Thoracic Endovascular Graft and Zenith Dissection Endovascular System.
• The associated device system is intended for endovascular treatment of appropriately selected thoracic aortic disease, including acute, complicated type B aortic dissection, according to the applicable device labeling.

Clinical Applications

• Endovascular repair of selected acute, complicated type B aortic dissection.
• Treatment of dissection-related thoracic aortic complications when endovascular stent-graft repair is indicated.
• Deployment of a proximal covered stent graft with a distal bare-metal stent to support the dissected aorta.

Reported off-label uses

• Use in selected chronic type B aortic dissections or post-dissection aneurysmal degeneration has been reported in clinical practice, but this may fall outside the device's specific FDA labeling.
• Use in other complex thoracic aortic anatomies may be considered in specialized practice, but should be evaluated against the current instructions for use and applicable regulatory requirements.

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

• Treatment requires detailed preprocedural CT angiography to assess the true and false lumens, proximal and distal landing zones, branch vessels, access arteries, and aortic diameter.
• The delivery system must be compatible with the patient's iliac and femoral access anatomy; vessel tortuosity, calcification, small diameter, or dissection can increase access and deployment risk.
• Available graft and stent dimensions, required landing zones, and device-specific sizing must be confirmed in the current instructions for use before treatment.
• MRI safety and conditional scanning requirements depend on the exact implanted components and labeling; the patient should retain the implant card and provide it to MRI staff.
• Potential complications include endoleak, persistent or recurrent dissection, aortic rupture, stroke, spinal cord ischemia, branch-vessel malperfusion, access-site injury, infection, and the need for reintervention.