MetaMedical™ Solutions Inc

Medtronic secures 510(k) clearance for bone ablation system

Medtronic has received 510(k) clearance from the US Food and Drug Administration (FDA) for the OsteoCool 2.0 ablation system to treat painful bone metastases.

The system is also designed to treat benign bone tumours such as osteoid osteoma.

It is an advancement over its predecessor and now supports the simultaneous use of four internally cooled probes.

Medtronic said that the enhancement allows physicians to perform multi-level spine tumour ablations or create larger ablation zones, offering increased flexibility and efficiency in procedures.

The new OsteoCool 2.0 system has a doubled probe count, making it possible to target two vertebral bodies concurrently or establish more extensive ablation zones for extra-spinal applications.

It is said to be the most potent bone tumour ablation system available, delivering 20W per channel, which is significantly higher than the 7.5W per channel offered by the Stryker OptaBlate system.

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Additionally, OsteoCool 2.0 provides the broadest range of probe sizes in the US market.

It is unique in the market, featuring the only bone tumour ablation system with internally cooled probes.

The system’s efficacy is supported by the OPuS One study, the largest of its kind, which showed rapid, significant, and long-lasting pain relief for cancer patients.

Medtronic plans to commence a limited market release of the OsteoCool 2.0 system immediately. It is planning for a broader launch across the US market later in the year.

Pain Interventions within the Neuromodulation vice-president and general manager David Carr said: “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.”

Earlier this year, the FDA approved Medtronic‘s Percept RC deep brain stimulation (DBS) system to help improve treatment for movement disorders.

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