Crf Radiofrequency Ablation System

FDA-Cleared Indications

• Used to ablate tumors using radiofrequency energy.

Clinical Applications

• Percutaneous radiofrequency ablation of appropriately selected tumors.
• Image-guided destruction of tumor tissue when local ablation is chosen as part of cancer treatment.
• Minimally invasive tumor ablation performed in a clinical setting.

Reported off-label uses

• Radiofrequency ablation of selected benign tumors or non-tumor tissue has been described for some radiofrequency ablation systems, but these applications may not be included in this device's FDA-cleared labeling.

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 treatment electrode, probe, and accessory sizes depend on the specific system configuration and target tumor.
• The device is generally used with imaging guidance, such as ultrasound, computed tomography, or magnetic resonance imaging, according to the product labeling and facility protocol.
• MRI compatibility is configuration-specific; confirm the labeling for the complete system and all accessories before scanning.
• Contraindications and precautions may include inability to safely reach the target, uncorrected bleeding risk, infection along the access path, or unsafe proximity to critical structures.
• Radiofrequency ablation is one treatment option; surgery, radiation therapy, systemic medication, or other ablation technologies may be appropriate depending on the tumor and patient.