Solero Microwave Tissue Ablation Mta System and Accessories

FDA-Cleared Indications

• Ablation of soft-tissue tumors.

Clinical Applications

• Image-guided percutaneous ablation of selected soft-tissue tumors.
• Microwave ablation of tumors when surgical resection is not feasible or appropriate.
• Treatment planning and ablation of tumors in organs such as the liver, lung, or kidney when the specific device configuration and tumor characteristics meet the applicable labeling.
• Use with imaging guidance, such as ultrasound or computed tomography, to place the ablation antenna and monitor treatment.

Reported off-label uses

• Microwave ablation of selected benign tumors or non-tumor tissue conditions has been reported for this device category, but such use may fall outside the device's FDA-cleared indication and should be evaluated under appropriate clinical and institutional oversight.

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 device is used with compatible microwave ablation antennas, cables, generators, and accessories; available antenna configurations and treatment zones should be confirmed before the procedure.
• Ultrasound or CT is commonly used for antenna placement, treatment planning, and monitoring. Tumor size, shape, location, and proximity to bowel, major vessels, bile ducts, ureters, nerves, or other critical structures affect eligibility and technique.
• The FDA record does not establish that the system or its accessories are MR Safe or MR Conditional. MRI use should not be assumed; consult the current manufacturer labeling before bringing any component into an MRI environment.
• Potential risks include bleeding, infection, injury to adjacent organs, thermal damage, incomplete treatment, tumor seeding along the antenna tract, and complications related to anesthesia or sedation.
• Treatment may require general anesthesia, deep sedation, or moderate sedation depending on the tumor location, number of ablations, patient condition, and institutional practice.