Solero Mta System Solero Microwave Tissue Ablation Applicator 14cm Solero Microwave Tissue Ablation Applicator 19cm Solero Microwave Tissue Ablation Applicator 29cm

FDA-Cleared Indications

• Ablation of soft-tissue tumors.
• Use when the tumor is accessible through a percutaneous or open surgical approach.

Clinical Applications

• Microwave ablation of soft-tissue tumors through a percutaneous approach.
• Microwave ablation of soft-tissue tumors during an open surgical procedure.
• Treatment of accessible tumors using image guidance for applicator placement and monitoring.

Reported off-label uses

• Microwave ablation of selected liver, lung, or kidney tumors when the specific clinical situation is outside the device labeling or institutional protocol.

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

• Applicators are available in 14 cm, 19 cm, and 29 cm lengths; selection depends on the access route, target depth, and anatomy.
• The applicator is typically placed under imaging guidance, such as ultrasound, computed tomography, or another suitable modality, depending on the procedure.
• The system is intended for use by clinicians trained in tumor ablation and in managing potential thermal injury, bleeding, infection, and damage to nearby structures.
• Microwave ablation equipment and applicators should not be assumed to be MRI safe or MR conditional. Follow the current manufacturer labeling before use in or near an MRI environment.
• Patient selection should account for tumor location, size, proximity to critical organs or vessels, bleeding risk, infection risk, and whether percutaneous or open access is appropriate.