Physician Industries Radiofrequency Ablation Needle

FDA-Cleared Indications

• Intended for use in radiofrequency ablation of tumors.
• Used to deliver radiofrequency energy to accessible target tissue during a percutaneous ablation procedure.

Clinical Applications

• Percutaneous radiofrequency ablation of selected tumors.
• Image-guided placement and treatment of tumors that can be reached safely through the skin.
• Tumor ablation when surgical resection is not feasible or is not selected as the treatment approach.
• Use with a compatible radiofrequency generator during an interventional oncology procedure.

Reported off-label uses

• Radiofrequency ablation of selected benign tumors or non-tumor tissue conditions has been described for some radiofrequency needle systems, but the specific use depends on the device labeling, generator, anatomy, and clinical evidence.

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 needle is generally used with ultrasound, CT, or another suitable imaging modality for accurate placement and monitoring.
• Available needle dimensions and active-tip configurations may vary; the treating clinician selects the configuration based on tumor size, location, and the desired ablation zone.
• The needle must be used with a compatible radiofrequency generator and according to the device labeling and generator instructions.
• MRI compatibility should not be assumed. Confirm the exact device labeling before bringing the needle into the MRI environment; radiofrequency ablation is commonly performed with CT or ultrasound guidance instead.
• Potential contraindications and precautions include inability to safely access the target, uncorrected bleeding risk, active infection along the access path, and proximity to critical structures without adequate protective techniques.