FDA approves expanded indication for OsteoCool RF Ablation System for palliative treatment of metastases in all bony anatomy- Medtronic

Medtronic announced that the FDA has cleared an expanded indication for the OsteoCool RF Ablation System. Originally cleared for use in the spine, the FDA now allows the marketing of the OsteoCool System for palliative treatment of metastases in all bony anatomy - such as ribs, sacrum, extremities, and hip - in patients who have failed or are not candidates for standard therapy. The system uses targeted radiofrequency energy to ablate malignant metastatic bone tumors.

Comment: The device also has a CE mark for the ablation of benign bone tumors such as osteoid osteoma and palliative treatment of metastatic malignant lesions involving bone, including the vertebral body. This indication is not available in the United States.