NeuWave Microwave Ablation System and Accessories

FDA-Cleared Indications

• Ablation of soft-tissue lesions using microwave energy to produce coagulative necrosis.
• Use with compatible microwave ablation accessories during minimally invasive ablation procedures.
• The FDA-cleared indication should be confirmed in the current device labeling for the specific generator, antenna, and accessory configuration.

Clinical Applications

• Image-guided ablation of selected liver tumors or other soft-tissue lesions when the procedure is appropriate.
• Percutaneous microwave ablation procedures performed under ultrasound, computed tomography, or other compatible imaging guidance.
• Use of compatible microwave ablation antennas and accessories to deliver energy to a targeted lesion.
• Thermal ablation procedures performed by qualified clinicians according to the system’s labeling and instructions for use.

Reported off-label uses

• Microwave ablation of osteoid osteoma has been described in clinical practice and medical literature, but the specific use should be confirmed against the applicable device labeling.
• Bronchoscopic microwave ablation of lung tissue has been described in clinical practice and literature; this may not be covered by the device’s FDA-cleared indication and should not be assumed to be on-label.

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 requires a compatible microwave antenna or probe; antenna length, active-tip length, shaft configuration, and gauge vary by accessory and intended approach.
• Procedures are typically performed with ultrasound, CT, or another compatible imaging modality, using sterile technique and either local anesthesia with sedation or general anesthesia depending on the site and approach.
• MRI compatibility is configuration-specific. Do not bring the generator, cables, antennas, or accessories into the MRI environment unless the current labeling specifically identifies them as MR Safe or MR Conditional under defined conditions.
• Important risks include bleeding, infection, injury to adjacent organs, thermal damage, pain, and incomplete treatment or tumor recurrence. Patient selection depends on lesion location, size, access route, coagulation status, and other comorbidities.
• The generator and accessories must be used together as specified in the instructions for use; compatibility, grounding, cooling, sterile packaging, and single-use requirements should be checked before the procedure.