Vici Venous Stent System

FDA-Cleared Indications

• Treatment of chronic iliofemoral venous outflow obstruction.
• Use in patients enrolled in the VIRTUS premarket study, with labeling updated to include final 3-year follow-up results.

Clinical Applications

• Endovascular stenting of chronic obstruction in the iliofemoral veins.
• Treatment of venous narrowing or blockage involving the iliac and common femoral venous outflow pathway.
• Placement through a catheter-based procedure to improve venous drainage and blood flow.

Reported off-label uses

• Treatment of selected venous obstructions outside the labeled iliofemoral anatomy, such as some central or upper-extremity venous lesions, when judged appropriate by a specialist.

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 stent is self-expanding and is delivered through a catheter under fluoroscopic or other image guidance.
• Available sizes and delivery-system requirements should be confirmed in the current manufacturer instructions for use; sizing depends on the treated vein and lesion length.
• The device is intended for venous anatomy and should not be used in arteries or outside the labeled indication without specialist assessment.
• MRI conditions should be checked in the current device labeling before scanning; patients should tell MRI staff that they have a venous stent.
• Contraindications and precautions include inability to receive appropriate antithrombotic treatment, active infection near the treatment site, unsuitable vessel size or anatomy, and significant untreated thrombus or obstruction.