Venovo Venous Stent System

FDA-Cleared Indications

• Treatment of symptomatic iliofemoral venous outflow obstruction.

Clinical Applications

• Endovascular treatment of symptomatic obstruction in the iliac and common femoral venous outflow pathways.
• Stent placement to maintain venous patency after treatment of an iliofemoral venous obstruction.
• Treatment of symptomatic venous outflow obstruction associated with chronic venous disease when the affected anatomy meets the device labeling.

Reported off-label uses

• Use in venous segments or clinical conditions outside the labeled iliofemoral indication may occur in practice, but this is off-label and should be determined by the treating 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 device is a self-expanding stent delivered through a catheter under fluoroscopic imaging, typically through femoral or other suitable venous access.
• The appropriate stent diameter and length depend on the patient's venous anatomy, the location and length of obstruction, and the manufacturer's sizing instructions.
• Patients require assessment for thrombus, vessel anatomy, bleeding risk, anticoagulation needs, and other causes of venous symptoms before treatment.
• MRI eligibility depends on the current device labeling and specified scanning conditions; the implant card and manufacturer instructions should be reviewed before MRI.
• Potential complications include stent migration, thrombosis or occlusion, vessel injury, bleeding at the access site, recurrent obstruction, and the need for additional treatment.