Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena Cava Filter Set for Jugular Appr

FDA-Cleared Indications

• Prevention of pulmonary embolism by placement in the inferior vena cava.
• Use in patients with a contraindication to anticoagulation therapy.
• Use when pulmonary embolism may recur despite adequate anticoagulation therapy.

Clinical Applications

• Percutaneous placement of a retrievable filter in the inferior vena cava.
• Pulmonary embolism protection when anticoagulation is contraindicated.
• Temporary protection during a period of elevated venous thromboembolism risk, when later retrieval is clinically appropriate.
• Placement through a femoral or jugular venous approach using fluoroscopic imaging.

Reported off-label uses

• Protection from pulmonary embolism in selected patients who cannot tolerate anticoagulation for reasons not specifically addressed in the device labeling.
• Use in selected complex venous thromboembolism cases when clinicians judge that standard labeled options are insufficient.

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 set is available for femoral and jugular venous approaches; access-site anatomy and the intended deployment location should be confirmed before the procedure.
• Placement is performed under fluoroscopic imaging, typically with local anesthetic and moderate sedation or another anesthesia plan based on the patient and procedure.
• The filter is intended to be retrievable, but retrieval depends on clinical need, filter position, clot burden, endothelial incorporation and other anatomic factors.
• MRI conditions should be confirmed from the current manufacturer labeling and implant documentation before scanning; MRI safety may depend on the specific filter configuration and field conditions.
• Contraindications and precautions include conditions that make venous access, IVC placement or filter deployment unsafe, as well as factors that increase the risk of bleeding, infection, migration or thrombosis.