Focus T41 T41F T43 T43F T44F

FDA-Cleared Indications

• Prevention of pulmonary embolism in patients at risk for embolic disease.
• Use in patients with contraindications to anticoagulation therapy.
• Use in patients with thromboembolic disease when mechanical protection from pulmonary embolism is indicated.

Clinical Applications

• Placement in the inferior vena cava to reduce the risk of pulmonary embolism.
• Protection from emboli in patients who cannot receive anticoagulant therapy.
• Use in selected patients with thromboembolic disease when an IVC filter is clinically indicated.
• Placement under fluoroscopic or other appropriate imaging guidance by qualified physicians.

Reported off-label uses

• Temporary protection from pulmonary embolism during selected high-risk periods when anticoagulation is interrupted.
• Use in selected patients with recurrent pulmonary embolism despite anticoagulation.

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 T41, T41F, T43, T43F, and T44F models may differ in size and configuration; the appropriate model should match the patient's IVC anatomy and the device labeling.
• Placement requires imaging guidance, commonly fluoroscopy, to identify the IVC and confirm filter position.
• Potential complications include filter migration, tilting, IVC perforation, access-site bleeding, and thrombosis or occlusion of the IVC.
• The device's MRI conditions and compatibility should be confirmed in the current manufacturer labeling before MRI.
• An IVC filter does not treat the underlying clot or replace anticoagulation when anticoagulation is safe and appropriate.