Medtronic has announced US Food and Drug Administration (FDA) 510(k) clearance and launch of the OsteoCool RF Ablation System
The OsteoCool System is a cooled radiofrequency (RF) ablation technology that provides dual-probe capabilities. Cooled RF ablation uses targeted high-frequency energy to destroy cancer cells in patients with spine metastases.
The OsteoCool 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.
Sandeep Bagla, an interventional radiologist with the Vascular Institute of Virginia in Woodbridge, said: "The most common complaint associated with spine metastases is pain - it's often progressive and significantly reduces the patient's quality of life.
"With the OsteoCool system, I can now ablate the patient's painful tumour with a reproducible procedure that's appropriate for their unique anatomy."
Julie Foster, general manager and vice president of the pain therapies business at Medtronic, said: "The OsteoCool System expands our Pain Therapies portfolio. 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."
Medtronic acquired the OsteoCool technology and associated intellectual property from Baylis Medical on December 16, 2015 and partnered with the company to further develop the system.
Kris Shah, president of Baylis Medical, said: "We're pleased to be partnering with Medtronic to improve the treatment of patients suffering from spinal metastases."
The device is currently pending CE mark, according to Medtronic.