Optease Vena Cava Filter and Optease Retrieval Cathteter

FDA-Cleared Indications

• Prevention of pulmonary embolism by trapping thromboemboli in the inferior vena cava.
• Use in patients at risk for pulmonary embolism who require temporary vena cava filtration.
• Use when anticoagulant therapy is contraindicated, ineffective, or not possible, according to the device labeling.

Clinical Applications

• Percutaneous placement in the inferior vena cava to reduce the risk of pulmonary embolism.
• Temporary protection for patients with venous thromboembolism who cannot receive anticoagulation.
• Use when pulmonary embolism risk persists despite anticoagulation or anticoagulation is not effective, when consistent with the cleared labeling.
• Percutaneous retrieval when protection is no longer needed and removal is clinically appropriate.

Reported off-label uses

• Prophylactic placement in selected trauma or surgical patients who do not have documented venous thromboembolism but are considered at high risk for pulmonary embolism.
• Use in selected patients with recurrent pulmonary embolism despite anticoagulation.

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 and positioned in the inferior vena cava under fluoroscopic imaging; venography may be used to assess anatomy before deployment.
• The device is intended for retrievable use, but removal may become difficult or impossible if the filter tilts, embeds, migrates, fractures, or develops substantial tissue growth.
• The access route and filter size must match the patient's venous anatomy and the device's labeled delivery-system requirements; the manufacturer’s current instructions for use should be checked.
• MRI conditions, including magnetic-field strength and scan parameters, should be verified in the current device labeling before imaging.
• Contraindications and precautions include unsuitable IVC anatomy, venous thrombosis at the intended access or deployment site, infection, contrast allergy, and inability to tolerate the procedure or necessary imaging.