Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface

FDA-Cleared Indications

• Approval for adding radiopaque markers to the endoprosthesis.
• The associated product code identifies this device category as an endovascular graft for treating stenosis in an arteriovenous dialysis access circuit.

Clinical Applications

• Endovascular treatment of stenosis in an arteriovenous dialysis access circuit, when covered by the applicable device labeling.
• Fluoroscopic placement of a covered endoprosthesis with radiopaque markers to support device positioning and visualization.
• Treatment of peripheral arterial disease only when the specific VIABAHN model and its labeling include the relevant peripheral artery indication.

Reported off-label uses

• Treatment of selected peripheral arterial lesions, including complex femoropopliteal disease and in-stent restenosis, with device selection based on the applicable labeling and patient anatomy.
• Exclusion of selected peripheral arterial aneurysms or pseudoaneurysms.
• Use in selected visceral or other branch-vessel aneurysm or pseudoaneurysm cases.
• Use in selected fenestrated or branched endovascular aortic repair configurations.

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

• Available diameters and lengths vary by model; sizing must match the target vessel, lesion, landing zones and access anatomy.
• The device is delivered through a compatible catheter system over a guidewire under fluoroscopic imaging. Vessel preparation, adequate landing zones and accurate deployment are important.
• The heparin bioactive surface is a device feature, not a substitute for the prescribed antiplatelet or anticoagulation plan.
• MRI conditions depend on the exact device model and current manufacturer labeling. Confirm MR Conditional requirements, including field strength and scanning limits, before MRI.
• Potential complications include thrombosis or occlusion, restenosis, migration, endoleak or persistent flow around the graft, vessel injury, bleeding, infection and need for reintervention. Contraindications and warnings must be checked in the current instructions for use.