Micro Thermx Microwave Ablation System and Accessories

FDA-Cleared Indications

• Ablation of soft-tissue tumors.

Clinical Applications

• Image-guided microwave ablation of soft-tissue tumors.
• Percutaneous tumor ablation when a clinician determines that microwave ablation is appropriate.
• Use by trained clinicians in a hospital or other clinical setting with imaging guidance for applicator placement and treatment monitoring.

Reported off-label uses

• Microwave ablation of selected tumors in organs such as the liver, lung, kidney, or bone when the specific application is not covered by the device labeling.
• Local treatment of recurrent or metastatic tumors in selected patients when surgery is not suitable.

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

• Applicator selection and energy settings depend on tumor size, shape, tissue type, and proximity to critical structures.
• Placement is typically performed with imaging guidance, such as computed tomography or ultrasound; the available guidance method depends on the treatment site and clinical setting.
• The system requires appropriate training in microwave ablation, sterile applicator handling, treatment planning, and management of potential thermal injury.
• MRI compatibility and safe use in an MRI environment should not be assumed; confirm the specific system, applicator, and accessories' labeling before MRI exposure.
• Patient-specific contraindications and precautions include inability to safely access the lesion, uncorrected bleeding risk, active infection at the access site, and tumor location near structures vulnerable to heat.