The original OsteoCool device 1st won 510(k) clearance in March 2012. A 2nd version landed another 510(k) in June 2015, and Montreal-based Baylis won a nod last November for the 3rd iteration. Medtronic said CE Mark approval in the European Union for the OsteoCool device is pending.
Fridley, Minn.-based Medtronic said it acquired OsteoCool Dec. 16, 2015, for an undisclosed amount. The OsteoCool device uses a pair of cooled radiofrequency probes to ablate cancerous lesions in the spine that have metastasized from other cancers.
“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 pain therapies vice president Julie Foster said in prepared remarks.
“We’re pleased to be partnering with Medtronic to improve the treatment of patients suffering from spinal metastases,” added Baylis president Kris Shah. “Our company has a long, established track record of developing innovative clinical solutions. We are excited that this partnership with Medtronic will enhance patient access to our novel spinal tumor ablation technology.”