Medtronic 6957

FDA-Cleared Indications

• Prevention of pulmonary embolism by trapping emboli in the inferior vena cava.
• Use in patients at risk for thromboembolic disease when anticoagulation therapy is contraindicated, ineffective, or not possible.

Clinical Applications

• Placement in the inferior vena cava to reduce the risk of pulmonary embolism.
• Protection from pulmonary embolism in patients who cannot receive anticoagulant medication.
• Use when thromboembolic risk persists despite anticoagulation or when anticoagulation is not clinically suitable.
• Placement during an IVC filter procedure using imaging guidance and venous access.

Reported off-label uses

• Temporary protection from pulmonary embolism in selected trauma patients at very high risk when anticoagulation is delayed or contraindicated.
• Use in selected patients with recurrent pulmonary embolism despite therapeutic 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 available labeling and public device information should be reviewed for the filter's dimensions, delivery-system requirements, and recommended venous access technique.
• The IVC should be evaluated with appropriate imaging before placement to assess anatomy, diameter, thrombus, and renal venous anatomy.
• Anticoagulation remains the usual treatment for venous thromboembolism when it can be given safely; an IVC filter does not treat existing deep-vein thrombosis.
• MRI safety and conditions should be confirmed from the device-specific labeling. Do not assume that a legacy filter is MR safe or MR conditional without documentation.
• Potential complications include access-site bleeding, filter migration, malposition, IVC perforation, filter thrombosis, recurrent deep-vein thrombosis, and pulmonary embolism.