Medtronic
(NYSE: MDT)
announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system.
The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to cool the probes in close proximity to the active tip to avoid excess heating.
With an upgraded design, the OsteoCool radiofrequency ablation system offers a number of new advantages over the previous generation. Medtronic’s system enables the simultaneous use of four internally-cooled probes. This allows physicians to ablate two vertebral bodies at once, or create larger ablation zones in extra-spinal applications.
According to a news release, it’s the most powerful bone tumor ablation system on the market, delivering 20W per channel. That comes in well ahead of the Stryker OptaBlate bone tumor ablation system (7.5W per channel), Medtronic claims. According to Medtronic, it also offers the widest selection of probe sizes in the U.S. market with four available options.
Medtronic said OsteoCool remains the only bone tumor ablation platform with internally-cooled probes on the market. It delivers predictable ablations, reducing the risk of heating around the lesion site with proven pain relief.
The company plans to kick off a limited market release of OsteoCool 2.0 immediately, with a broad U.S. rollout planned for later this year.
“OsteoCool 2.0 is a welcome upgrade to our interventional portfolio and further cements our status as offering the most innovative and comprehensive pain management portfolio in the industry,” said David Carr, VP and GM of Pain Interventions within the Neuromodulation business at Medtronic.