Modification to Viabahn Endoprosthesis

FDA-Cleared Indications

• Treatment of peripheral vascular disease involving stenotic or occluded vessels when endovascular stent-graft treatment is appropriate.
• Exclusion or treatment of selected peripheral arterial aneurysms or pseudoaneurysms.
• Treatment of vascular lesions where a covered endoprosthesis is needed to maintain vessel patency and exclude the lesion from blood flow.

Clinical Applications

• Endovascular treatment of selected peripheral arterial stenoses or occlusions.
• Exclusion of selected peripheral arterial aneurysms or pseudoaneurysms.
• Revascularization of diseased peripheral arteries using a covered stent graft.
• Placement through a catheter, commonly from femoral arterial access, with fluoroscopic angiographic guidance.

Reported off-label uses

• Treatment of selected complex visceral or renal artery aneurysms and pseudoaneurysms.
• Use in selected dialysis access circuit or fistula-graft complications, such as recurrent stenosis, pseudoaneurysm, or rupture.
• Treatment of selected iliac or other complex arterial lesions outside the device's specific labeled indication.

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 required diameter and length depend on the target vessel, lesion, landing zones, and the manufacturer's sizing instructions; adequate healthy vessel is needed for secure sealing and fixation.
• The delivery system must be compatible with the planned access route and vessel diameter. Device deployment requires accurate angiographic positioning because repositioning may not be possible after release.
• Potential complications include thrombosis, restenosis, migration, endoleak or persistent flow around the graft, vessel injury, bleeding at the access site, infection, and need for reintervention.
• MRI safety and scanning conditions depend on the exact Viabahn model and implanted configuration. The current device labeling should be checked before MRI; patients should provide the implant identification card to the MRI facility.
• Contraindications and precautions include unsuitable vessel size or anatomy, inability to receive required antiplatelet or anticoagulant therapy, active infection involving the treatment site, and allergy or sensitivity to device materials or contrast when it cannot be managed.