Optease Vena Cava Filter and Retrieval Catheter

FDA-Cleared Indications

• Prevention of pulmonary embolism in patients at risk for venous thromboembolism.
• Use when anticoagulant therapy is contraindicated, unsuccessful, or not tolerated.
• Temporary placement in the inferior vena cava with intended retrieval when protection from pulmonary embolism is no longer needed.

Clinical Applications

• Percutaneous placement in the inferior vena cava to prevent pulmonary embolism.
• Temporary protection from pulmonary embolism in patients who cannot receive anticoagulation.
• Use in selected patients with venous thromboembolism despite anticoagulation, when clinically indicated by the treating team.
• Retrieval after the risk of pulmonary embolism has decreased or anticoagulation can be used safely.

Reported off-label uses

• Prophylactic placement in selected high-risk trauma patients without documented venous thromboembolism.
• Use in selected patients with limited cardiopulmonary reserve who are considered at unusually high risk from pulmonary embolism.

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, commonly through femoral or jugular venous access, under fluoroscopic imaging.
• Available filter and catheter sizes, deployment limits, and retrieval requirements must be matched to the patient's IVC diameter and anatomy according to the current instructions for use.
• Retrieval should be considered once protection is no longer clinically needed because prolonged dwell time can make removal more difficult and may increase device-related complications.
• MRI conditions and artifact depend on the specific device labeling; confirm the current manufacturer MRI guidance before scanning.
• Potential complications include filter migration, tilt, fracture, IVC perforation, access-site bleeding, caval thrombosis, and difficulty or failure of retrieval.