Medtronic’s OsteoCool System Granted Expanded Indication by FDA for the Palliative Treatment of Metastatic Bone Tumors


February 15, 2017—Medtronic announced that the US Food and Drug Administration has approved an expanded indication for its OsteoCool RF Ablation System for the palliative treatment of metastatic bone tumors. The OsteoCool System had previously been approved for use in the spine.

Medtronic describes the OsteoCool System as a cooled radiofrequency (RF) ablation technology with simultaneous, dual-probe capabilities that provide procedural flexibility and predictable, customized treatment. The system is temperature controlled and uses internally water-cooled probes to prevent overheating of surrounding tissue during the procedure.

Per the company’s announcement, the new indication enables the system to be used to provide palliative treatment to patients who have failed or are not candidates for standard therapy and have metastases in all types of bony anatomy, including ribs, sacrum, extremities, and hip. Medtronic explained that the system uses targeted RF energy to ablate malignant metastatic bone tumors.

"Patients with metastatic bone cancer may be treated with conventional therapies such as opioids, chemotherapy, or radiation therapy for pain palliation," commented Sandeep Bagla, MD, an interventional radiologist with the Vascular Institute of Virginia in Woodbridge, Virginia, in the company’s announcement. "With the expanded indication for the OsteoCool System, I now have the option to ablate these patients' painful bone tumors when conventional therapies are considered ineffective, too slow-acting, or cause unacceptable side effects."

Medtronic acquired the OsteoCool technology from Baylis Medical in 2015. The company also noted that the device is CE Mark approved in Europe for the ablation of benign bone tumors (eg, osteoid osteoma) and palliative treatment of metastatic malignant lesions involving bone, including the vertebral body. This indication is not available in the United States.


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