Medtronic plc announced it has received FDA clearance for an expanded indication for the OsteoCool radiofrequency ablation system to be used as palliative treatment for metastases in all bony anatomy. The device was originally cleared by the FDA for use in the spine, according to a company press release.
“Our Pain Therapies business is deeply rooted in the Medtronic mission – which calls us to alleviate pain,” Jeff Cambra, general manager of the Pain Therapies Interventional business, which is part of the Restorative Therapies Group at Medtronic, said in the release. “With this expanded indication, we put an important treatment option into the hands of physicians so that they can help more patients suffering from debilitating pain.”
According to the release, the OsetoCool system is the only cooled radiofrequency ablation system with simultaneous dual-probe capabilities and offers procedural flexibility and customized treatment. OsteoCool also has a CE mark for the ablation of benign bone tumors, such as osteoid osteoma, and palliative treatment of metastatic malalignment lesions that involve the bone. However, this indication does not apply in the United States.