Solero Microwave Tissue Ablation Mta System and Accessories

FDA-Cleared Indications

• Ablation of soft-tissue tumors.
• Use with compatible microwave ablation antennas and accessories as specified in the FDA-cleared labeling.

Clinical Applications

• Image-guided percutaneous ablation of soft-tissue tumors.
• Microwave ablation performed by trained clinicians in interventional oncology or related procedural settings.
• Use during minimally invasive tumor treatment when the treating team determines that ablation is appropriate.

Reported off-label uses

• Microwave ablation of benign tumors or non-tumor tissue is reported in clinical practice for some device categories, but may fall outside the specific FDA-cleared indication and should not be assumed to be labeled use.

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 is used with microwave antennas or probes selected for the target lesion, access route, and intended ablation zone.
• Placement is generally performed with imaging guidance, such as ultrasound, computed tomography, or magnetic resonance imaging, according to the antenna and system labeling.
• The system is not automatically MRI safe; MRI use requires confirmation of the exact system, antenna, accessories, and conditions in the current manufacturer labeling.
• Treatment requires trained personnel familiar with microwave ablation, image-guided needle placement, thermal injury prevention, and management of bleeding or other complications.
• Patient selection depends on tumor location, size, number, adjacent organs, bleeding risk, infection risk, and available alternatives such as surgery, radiation, systemic medication, or other ablation methods.