Cook Clect Vena Cava Filter Gunther Tulip Vena Cava Filter Retrieval Set

FDA-Cleared Indications

• Prevention of recurrent pulmonary embolism in patients with contraindications to anticoagulation therapy.
• Prevention of recurrent pulmonary embolism in patients who experience recurrent embolism despite adequate anticoagulation.

Clinical Applications

• Placement in the inferior vena cava to prevent recurrent pulmonary embolism.
• Use in patients who cannot receive anticoagulant medication because of a contraindication.
• Use in patients with recurrent pulmonary embolism despite adequate anticoagulation.
• Percutaneous IVC filter placement using an imaging-guided delivery system.
• Percutaneous retrieval when the filter is no longer clinically needed, when retrieval is feasible and appropriate.

Reported off-label uses

• Temporary pulmonary embolism protection in selected high-risk patients who do not meet the labeled indications, such as some trauma or perioperative patients.
• Use as prophylaxis against pulmonary embolism in selected patients without documented recurrent embolism or a contraindication to 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 IVC should be evaluated with appropriate imaging before placement, including assessment of diameter, thrombus, renal veins and other relevant anatomy.
• The device is available in size configurations intended for different IVC diameters; clinicians should confirm the current instructions for use and compatible delivery system before the procedure.
• Placement and retrieval are typically performed through venous access, commonly the internal jugular or common femoral vein, with fluoroscopic or other appropriate imaging guidance.
• Retrieval may become more difficult as dwell time increases or if the filter tilts, becomes embedded, penetrates the IVC wall or develops substantial thrombus. Retrieval should be considered when protection is no longer needed and the benefits outweigh the risks.
• MRI safety and conditions depend on the specific filter model and current labeling. The device and its instructions for use should be verified before MRI; MRI conditional status should not be assumed from the device category alone.