Viabahn Endoprosthesis

FDA-Cleared Indications

• Treatment of peripheral arterial disease involving stenotic or occluded peripheral arteries.
• Endovascular repair of lesions in the superficial femoral artery and popliteal artery.
• Treatment of in-stent restenosis in the femoropopliteal arteries, when covered-stent use is included in the applicable device labeling.

Clinical Applications

• Endovascular treatment of symptomatic femoropopliteal artery stenosis or occlusion.
• Placement across complex or long lesions in the superficial femoral artery or popliteal artery.
• Treatment of femoropopliteal in-stent restenosis when the device is used according to its current labeling.
• Deployment through a catheter under fluoroscopic or angiographic guidance after vessel preparation, such as balloon angioplasty.

Reported off-label uses

• Endovascular exclusion of selected peripheral artery aneurysms or pseudoaneurysms.
• Treatment of selected traumatic or iatrogenic peripheral arterial injuries.
• Covered-stent treatment of selected dialysis access or visceral artery complications.

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 available in multiple diameters and lengths; selection depends on the target vessel diameter, lesion length, landing zones, and required vessel coverage.
• It is delivered through a compatible catheter system and deployed by controlled release under fluoroscopic or angiographic guidance.
• Adequate proximal and distal landing zones are needed to reduce migration, endoleak around the treated segment, and restenosis.
• MRI safety depends on the specific device labeling, field strength, implant configuration, and conditions stated by the manufacturer; the implant card and current instructions for use should be checked before scanning.
• Contraindications and precautions include unsuitable vessel anatomy, inadequate access, active infection at the treatment site, inability to receive recommended antiplatelet or anticoagulant therapy, and severe contrast or renal-related concerns as clinically applicable.