Irish medical technology firm Medtronic has received 510(k) approval from the US Food and Drug Administration (FDA) for its OsteoCool radiofrequency (RF) ablation system.


To treat patients with painful spine metastases, OsteoCool system is claimed to be the only cooled RF ablation technology that provides simultaneous and dual-probe capabilities.

OsteoCool system, which is temperature controlled, uses internally water-cooled probes to prevent overheating of surrounding tissue during the procedure.

The 17-gauge bipolar probes are available in three lengths, which can be used through a variety of cannula sizes.

Medtronic restorative therapies group Neuromodulation division’ pain therapies business vice president and general manager Julie Foster said: "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, the company also obtained FDA approval for expanded indications of Kyphon Xpede bone cement, allowing to treat microfracture that will be caused by cancer cells breaking down bone (forming osteolytic lesions).

The OsteoCool bone access kit will be used for a subsequent and physician-directed procedure such as cementoplasty (vertebroplasty or kyphoplasty).

According to the company, OsteoCool system is currently pending CE marking.

In December, Medtronic purchased the OsteoCool technology and associated intellectual property from Baylis Medical. It also collaborated with the company to further develop the system.

Baylis Medical president Kris Shah said: "We’re pleased to be partnering with Medtronic to improve the treatment of patients suffering from spinal metastases."

Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.