Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach

FDA-Cleared Indications

• Prevention of pulmonary embolism in patients at risk for pulmonary embolism when anticoagulation therapy is contraindicated.
• Placement in the inferior vena cava using either a femoral or jugular venous approach.

Clinical Applications

• Temporary IVC filter placement for patients at risk of pulmonary embolism who cannot receive anticoagulants.
• Retrievable IVC filter placement through the femoral vein.
• Retrievable IVC filter placement through the internal jugular vein.
• Capture of thrombi traveling through the inferior vena cava to help prevent pulmonary embolism.

Reported off-label uses

• Use in selected patients who can receive anticoagulation but have an unusually high risk of pulmonary embolism.
• Use as protection during selected procedures with a concern for embolization, when the treating team determines that the potential benefits outweigh the risks.

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 intended for placement in the inferior vena cava and is delivered through a compatible catheter system from either the femoral or jugular venous approach.
• The filter is retrievable, but removal depends on the patient’s condition, filter position, clot burden, endothelialization and the treating physician’s assessment.
• Filter size selection and deployment require measurement of the IVC and review of the device-specific instructions for use; the filter should not be placed outside its labeled vessel and size limits.
• MRI safety and scan conditions should be confirmed in the current manufacturer’s instructions for use before imaging. MRI eligibility can depend on field strength and other scanning parameters.
• Potential complications include access-site bleeding, filter migration, tilting, fracture, perforation of the IVC, thrombosis and difficulty or inability to retrieve the filter.