Lv Liberty Vision Model 1 90 Yttrium Brachytherapy Source

FDA-Cleared Indications

• Use as a sealed radioactive source for therapeutic brachytherapy applications.
• Use to deliver yttrium-90 radiation during catheter-based treatment of selected tumors.

Clinical Applications

• Y-90 radioembolization, also called selective internal radiation therapy (SIRT), for selected liver tumors.
• Catheter-directed delivery of yttrium-90 radiation to tumor-feeding arterial branches.
• Treatment planning and delivery performed by qualified interventional radiology and oncology teams in an appropriately licensed radiation-use facility.

Reported off-label uses

• Treatment of selected metastatic liver tumors when the specific tumor type, treatment approach, or clinical circumstance is outside the device labeling.

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 radioactive source requires handling, storage, transport, administration, and disposal under applicable radiation-safety regulations.
• It is used with compatible catheter-based delivery systems and image guidance; the source is not placed surgically directly into the tumor.
• Treatment requires careful angiographic planning to assess liver arterial anatomy and reduce delivery to non-target organs such as the stomach or bowel.
• MRI safety and device compatibility should be confirmed with the current manufacturer labeling and facility policies; radioactive source components should not be assumed to be MRI safe.
• Contraindications and precautions may include unsafe arterial anatomy, significant non-target blood flow, severe liver dysfunction, pregnancy, or inability to comply with radiation-safety instructions.