Cordis Optease Permanent Vena Cava Filter Models 466-f200a 466-f200b

FDA-Cleared Indications

• Prevention of pulmonary embolism by trapping thrombi in the inferior vena cava.
• Use in patients at risk for pulmonary embolism who have a contraindication to anticoagulant therapy.
• Use in patients with recurrent pulmonary embolism despite anticoagulant therapy.

Clinical Applications

• Permanent IVC filter placement for pulmonary embolism prevention.
• Protection from pulmonary embolism in patients with venous thromboembolism who cannot receive anticoagulation.
• Pulmonary embolism prevention when embolic events recur despite anticoagulant therapy.

Reported off-label uses

• Temporary protection during a short period of exceptionally high embolic risk when anticoagulation cannot be used, although this permanent filter is not designed for routine retrieval.
• Use in selected patients with free-floating or large deep-vein thrombus when clinicians judge pulmonary embolism risk to be substantial.

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 listed models are 466-F200A and 466-F200B; the appropriate filter size and delivery system depend on IVC diameter and the device labeling.
• Placement is generally performed through percutaneous venous access, commonly the internal jugular or common femoral vein, using fluoroscopic imaging.
• This is a permanent filter. Retrieval is not the intended routine management, and later removal may be difficult or not possible.
• Patients should be evaluated for contraindications, including unsuitable IVC anatomy, active infection at the access site, or other conditions identified in the current manufacturer labeling.
• MRI safety and scanning conditions must be confirmed from the current device-specific labeling and implant documentation before MRI.