Solero Microwave Tissue Ablation Mta System and Accessories

FDA-Cleared Indications

• The system is indicated for the ablation of soft-tissue tumors.
• It is used to deliver microwave energy to a targeted tumor and create coagulative necrosis.

Clinical Applications

• Image-guided percutaneous ablation of soft-tissue tumors.
• Microwave ablation of selected tumors in organs such as the liver, kidney, or lung when consistent with the device labeling and clinical judgment.
• Tumor ablation performed with CT, ultrasound, or other appropriate imaging guidance.
• Use in an interventional radiology suite or operating room as part of a planned tumor-treatment procedure.

Reported off-label uses

• Microwave ablation of selected bone or soft-tissue lesions has been described in clinical practice, but these applications may fall outside the device's FDA-cleared indication and require specialist judgment.

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 system uses dedicated microwave applicators available in different configurations and sizes; applicator selection depends on tumor size, location, access route, and the planned ablation zone.
• Procedures generally require CT or ultrasound guidance, sterile technique, and careful planning to protect adjacent organs, vessels, bile ducts, airways, or other critical structures.
• The generator and applicators should be used according to the current manufacturer labeling, including instructions for connection, energy delivery, cooling, cleaning, and handling.
• MRI compatibility should not be assumed. The generator, cables, and applicators require verification against the current labeling before use in or near an MRI environment.
• Patient selection depends on tumor characteristics, bleeding and infection risk, organ function, accessibility, and whether surgery, radiation, systemic therapy, or surveillance may be more appropriate.