Percutaneous Greenfield Vena Cava Filter System

FDA-Cleared Indications

• Prevention of pulmonary embolism by trapping thrombi in the inferior vena cava.
• Use in patients at risk for pulmonary embolism when anticoagulant therapy is contraindicated or ineffective.

Clinical Applications

• Percutaneous placement in the inferior vena cava for pulmonary embolism protection.
• Protection from pulmonary embolism in patients with venous thromboembolism who cannot receive anticoagulation.
• Use when pulmonary embolism risk persists despite anticoagulant treatment.

Reported off-label uses

• Prophylactic placement in selected patients at exceptionally high risk for venous thromboembolism who do not have documented acute venous thromboembolism.
• Use for prevention of pulmonary embolism in selected high-risk trauma or surgical patients when the expected benefit is judged to outweigh device-related 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, usually through percutaneous venous access with fluoroscopic imaging.
• Available filter sizes and delivery-system dimensions depend on the specific model and labeling; vessel diameter should be assessed before placement.
• The device is a permanent vena cava filter unless the specific model labeling states otherwise; retrieval should not be assumed.
• MRI safety and conditions depend on the exact filter model and its labeling. Confirm the model and current MRI instructions before scanning.
• Potential complications include access-site bleeding, filter migration, malposition, vena cava perforation, filter thrombosis, recurrent pulmonary embolism, and long-term changes in the vena cava.