Gore R Viabahn R Fortegra Venous Stent

FDA-Cleared Indications

• Treatment of symptomatic inferior vena cava obstruction.
• Treatment of symptomatic inferior vena cava obstruction with combined iliofemoral obstruction.

Clinical Applications

• Endovascular treatment of symptomatic inferior vena cava obstruction.
• Treatment of symptomatic obstruction involving the inferior vena cava and iliofemoral venous segments.
• Placement during image-guided venous recanalization and stenting procedures.
• Maintaining venous patency after treatment of an obstructed central or iliofemoral venous segment when the anatomy meets the device labeling.

Reported off-label uses

• Treatment of venous obstructions in anatomic locations or clinical situations not included in the FDA indication may be reported in clinical practice, but such use is off-label and should be considered by the treating specialist on an individual basis.

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 appropriate stent diameter and length depend on venous anatomy, the extent of obstruction, and the intended landing zones; pre-procedure cross-sectional imaging and venography help guide sizing.
• The device is delivered through a catheter system and typically deployed under fluoroscopic or other appropriate imaging guidance by an experienced venous intervention team.
• Clinicians should review the current manufacturer instructions for available sizes, delivery-system requirements, deployment technique, access-site requirements, and overlap or extension recommendations.
• MRI safety and scanning conditions depend on the device's current labeling, including field strength and specific scan parameters; verify the latest MR-conditional information before imaging.
• Contraindications, warnings, and precautions include factors such as unsuitable venous anatomy, inability to obtain appropriate vascular access, active infection at the treatment site, or conditions that prevent safe anticoagulation or antiplatelet management. The current FDA-approved labeling should be reviewed before use.