Cook Celect and Gunther Tulip Vena Cava Filter Sets

FDA-Cleared Indications

• Prevention of pulmonary embolism by placement of a filter in the inferior vena cava.
• Use in patients with a contraindication to anticoagulant therapy.

Clinical Applications

• Percutaneous placement of an IVC filter in patients who cannot receive anticoagulation.
• Protection from pulmonary embolism in selected patients at risk for venous thromboembolism.
• Placement through a venous access site under fluoroscopic imaging guidance.

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 filter is delivered through a catheter inserted into a vein, commonly the internal jugular or common femoral vein, and positioned in the IVC under fluoroscopy.
• Available filter and delivery-system sizes depend on the specific Celect or Günther Tulip configuration and the patient's IVC diameter; sizing must follow the current manufacturer instructions for use.
• The device is intended for use in the IVC and should not be placed when the vessel anatomy, thrombus burden, or access route is unsuitable.
• MRI conditions and allowable scanning parameters depend on the exact model and current labeling; confirm MR status before scanning.
• Potential complications include access-site bleeding, filter migration or tilt, IVC perforation, filter thrombosis, recurrent pulmonary embolism, and difficulty with retrieval. Retrieval should be considered when protection is no longer needed and is clinically appropriate.