Medtronic’s OsteoCool 2.0 Bone Tumor Ablation System Cleared by FDA

March 1, 2024—Medtronic announced that it has received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system to treat painful bone metastases and benign bone tumors such as osteoid osteoma. Medtronic will initiate a limited market release of OsteoCool 2.0 immediately, with a broad United States market launch planned for later this calendar year.

According to the company, the device is an upgraded design of the OsteoCool radiofrequency (RF) ablation system and brings several new advantages over the previous system. It allows for the simultaneous use of four internally cooled probes, enabling physicians to ablate two vertebral bodies at once or create larger ablation zones in extra-spinal applications. Additionally, OsteoCool 2.0 delivers 20 watts per channel and offers a wide selection of probe sizes with four available options in the United States.

Medtronic stated that the OsteoCool bone tumor ablation platform delivers predictable ablations, reduced risk of excess heating around the lesion site, and proven pain relief. The technology is backed by the large OPUS One study of RF ablation in bone metastases, which demonstrated swift (within 3 days), significant, and sustained (through 12 months) improvements in pain relief for cancer patients.

“Patients with metastatic disease to the spine often experience severe pain that significantly decreases their quality of life,” commented Jonathan Morris, MD, in the company’s press release. “OsteoCool 2.0 builds upon our years of experience with the previous generation, better enabling me to relieve pain in those suffering and return them to their normal activities.” Dr. Morris is a neuroradiologist at the Mayo Clinic in Rochester, Minnesota.