Medtronic announced the US Food and Drug Administration (US FDA) 510(k) clearance and the US launch of the OsteoCool RF Ablation System. For physicians who treat patients with painful spine metastases, the OsteoCool System is the only cooled radiofrequency (RF) ablation technology that offers simultaneous, dual-probe capabilities - providing procedural flexibility and predictable, customized treatment. Cooled RF ablation uses targeted high-frequency energy to destroy cancer cells.

"The OsteoCool System expands our Pain Therapies portfolio," said Ms Julie Foster, general manager and vice president of the Pain Therapies business in the Neuromodulation division, which is part of the Restorative Therapies Group at Medtronic. "Our customers treat patients with Kyphon Balloon Kyphoplasty who also have painful spinal metastases. The OsteoCool system gives physicians a way to treat that pain in a single procedure with a familiar, minimally invasive technique."

In November, Medtronic received expanded indications for Kyphon Xpede Bone Cement, which now includes clearance for the treatment of microfractures that can be caused by cancer cells breaking down bone (forming osteolytic lesions). Where indicated, the OsteoCool Bone Access Kit can be used for a subsequent, physician-directed procedure such as cementoplasty (i.e., vertebroplasty or kyphoplasty).

Medtronic acquired the OsteoCool technology and associated intellectual property from Baylis Medical on December 16, 2015 and partnered with the company to further innovate the system. Terms of the acquisition were not disclosed.

The system is temperature controlled and uses internally water-cooled probes to prevent overheating of surrounding tissue during the procedure. The 17-gauge, bipolar probes are available in three lengths and may be used through a variety of cannula sizes. Because two OsteoCool RF ablation probes can be used simultaneously, the system supports a variety of ablation scenarios accommodating unique patient and procedural needs. The device is currently pending CE marking.