Celect Platinum Vena Cava Filter Set for Femoral Vein Approach Igtcfs-65-1-Fem-Celect-Pt Celect Platinum Vena Cava Filter Set for Jugular Vein Approach Igtcfs-65-1-Jug-Celect-Pt Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach Igtcfs-65-1-Uni-Celect-Pt Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Igtcfs-65-1-Fem-Tulip Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach Igtcfs-65-1-Jug-Tulip Gunther Tulip Vena Cava Filter

FDA-Cleared Indications

• Prevention of pulmonary embolism by placement in the inferior vena cava.
• Use in patients at risk of pulmonary embolism when anticoagulant therapy is contraindicated.
• Use in patients at risk of pulmonary embolism when anticoagulant therapy has failed.
• The filters may be retrieved when clinically appropriate or left in place according to the treating physician's assessment.

Clinical Applications

• Percutaneous IVC filter placement through a femoral or jugular venous approach.
• Pulmonary embolism prevention in patients who cannot receive anticoagulation.
• Pulmonary embolism prevention when embolic events occur despite anticoagulation.
• Temporary IVC filtration when later retrieval is clinically appropriate.
• Permanent IVC filtration when retrieval is not indicated or cannot be performed.

Reported off-label uses

• Selected protection from embolization during treatment of extensive lower-extremity or pelvic venous thrombosis.
• Selected use during procedures with a substantial risk of thrombus embolization when standard labeling does not specifically address the situation.

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 listed sets are designed for femoral, jugular, or either venous access route, depending on the model.
• Placement is performed under fluoroscopic or other appropriate imaging guidance, generally through a percutaneous venous sheath.
• The treating physician must select the appropriate filter and delivery system based on IVC anatomy, vessel diameter, thrombus burden, and access route.
• Retrieval should be considered when protection is no longer needed and should follow the device labeling and the patient's clinical circumstances.
• MRI conditions, contraindications, and compatibility should be confirmed in the current manufacturer instructions for use; do not assume MRI safety from the device name alone.