Medtronic gets FDA green light for upgraded bone tumor ablation system

Medtronic has secured an FDA green light for an upgraded version of its radiofrequency ablation platform aimed at treating bone tumors, including cancer metastases as well as benign lesions such as osteoid osteomas.

The OsteoCool 2.0 system doubles the probe count compared to its predecessor, allowing the simultaneous use of four internally cooled probes and the ability for surgeons to ablate two vertebrae at once. The additions can also be used together to create larger ablation zones outside of the spine, the company said in its announcement.

According to Medtronic, between 60% and 80% of patients with metastatic disease may develop painful tumors in bone, most frequently among those with primary breast, prostate or lung cancer.

Bone tumor ablation is a minimally invasive pain management procedure that relies on needlelike probes to deliver radiofrequency energy, which then heats and destroys the tumor. The device also circulates water to cool the probes close to their active tips to avoid delivering excess heat to the surrounding healthy tissue.

Now with a 510(k) clearance in hand, Medtronic said it plans to begin a limited market release of the OsteoCool 2.0 immediately, with a broader U.S. launch set for later this year. 

Medtronic acquired the first OsteoCool device through a 2015 deal with Baylis Medical. Subsequent go-aheads from the FDA opened up its use from palliatively treating the spinal vertebrae to other bones such as the ribs, extremities and hips.

A previous OsteoCool clinical trial showed improvements in pain and quality of life starting three days after the procedure, lasting up to one year.