Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface

FDA-Cleared Indications

• Endovascular treatment of peripheral arterial disease involving the superficial femoral artery.
• Treatment of appropriate femoropopliteal arterial lesions with a self-expanding covered stent graft.
• Treatment of in-stent restenosis in the superficial femoral artery, when covered stent graft treatment is indicated.
• The 2019 PMA supplement described in this record added a manufacturing line at a packaging-component supplier; it did not establish a new clinical indication.

Clinical Applications

• Covered stent-graft placement for selected superficial femoral artery stenosis or occlusion.
• Endovascular treatment of complex femoropopliteal peripheral artery disease.
• Treatment of selected superficial femoral artery in-stent restenosis.
• Use during peripheral artery stenting to create a supported channel and maintain vessel patency.

Reported off-label uses

• Selected peripheral arterial aneurysms or pseudoaneurysms outside the labeled indication.
• Selected traumatic or iatrogenic peripheral arterial injuries when covered stent-graft repair is clinically appropriate.
• Selected dialysis access circuit stenosis or pseudoaneurysm repairs, depending on device labeling, anatomy, and local practice.

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

• The device is self-expanding and available in multiple diameters and lengths; sizing must match the target vessel, lesion length, landing zones, and the specific device instructions for use.
• It is delivered through a compatible catheter or sheath under fluoroscopic imaging, commonly through femoral arterial access. Adequate vessel access and landing zones are required.
• The device should not be used when anatomy, vessel diameter, access, or lesion characteristics fall outside the product labeling. Active infection, unsuitable landing zones, or inability to maintain required antiplatelet therapy may also affect candidacy.
• MRI conditions depend on the specific VIABAHN model, size, and labeling. Confirm the exact device and follow the current manufacturer MRI conditions before scanning.
• Potential complications include thrombosis or occlusion, restenosis, stent-graft migration or fracture, bleeding at the access site, distal embolization, vessel injury, and the need for repeat intervention.