Titanium Greenfield Vena Cava Filter Carrier

FDA-Cleared Indications

• Prevention of recurrent pulmonary embolism through placement in the inferior vena cava.
• Use in patients with thromboembolic disease when anticoagulant therapy is contraindicated.
• Use when anticoagulant therapy is unsuccessful or complications from anticoagulation occur.

Clinical Applications

• Percutaneous placement in the inferior vena cava.
• Protection against pulmonary embolism in selected patients with deep venous thrombosis.
• Pulmonary embolism prevention when anticoagulation cannot be given.
• Pulmonary embolism prevention when anticoagulation has failed or caused complications.

Reported off-label uses

• Prophylactic placement in selected patients at high risk for venous thromboembolism who do not have documented acute venous thrombosis.
• Use in selected trauma or surgical patients when temporary protection from pulmonary embolism is considered necessary.

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

• This is a permanent filter design; retrieval is not generally the intended use.
• Placement requires a compatible delivery system and imaging guidance, commonly through venous access in the neck or groin.
• The appropriate filter and carrier size depend on the delivery system, venous anatomy, and inferior vena cava dimensions specified in the device labeling.
• MRI safety and conditions should be confirmed from the original device labeling or manufacturer records before scanning; older records may not provide current MR-conditional information.
• Contraindications and precautions include inability to access the venous system, unsuitable inferior vena cava anatomy, active infection at the access site, and a contraindication to the required procedure or contrast agent.