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February 16, 2017

US FDA grants expanded indication for Medtronic’s OsteoCool ablation system

The US Food and Drug Administration (FDA) has granted expanded indication for the medical technology firm Medtronic's OsteoCool RF ablation system.

The US Food and Drug Administration (FDA) has granted expanded indication for the medical technology firm Medtronic's OsteoCool RF ablation system.

Initially cleared for use in the spine, the FDA now enables marketing of the OsteoCool System for palliative treatment of metastases in all bony anatomy such as ribs, sacrum, extremities and hip in patients who have failed or are not candidates for standard therapy.

The ablation system is a minimally-invasive procedure and uses targeted radiofrequency energy to ablate malignant metastatic bone tumours.

"With this expanded indication, we put an important treatment option into the hands of physicians so that they can help more patients suffering from debilitating pain."

Medtronic Pain Therapies Interventional business general manager Jeff Cambra said: "Our Pain Therapies business is deeply rooted in the Medtronic Mission, which calls us to alleviate pain.

"With this expanded indication, we put an important treatment option into the hands of physicians so that they can help more patients suffering from debilitating pain."

In December 2015, the firm purchased the OsteoCool technology and associated intellectual property from Baylis Medical and partnered with the company to further innovate the system.

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Baylis Medical president Kris Shah said: "The expansion of the OsteoCool System to include the ablation of malignant lesions in bone adds to our company's track record of offering innovative clinical solutions and further enhancing patient access and treatment options."

The ablation system is claimed to provide simultaneous, dual-probe capabilities which allow procedural flexibility and predictable, customised treatment. It is temperature controlled and has internally water-cooled probes, which prevent overheating of surrounding tissue during the procedure.

The firm has also secured CE mark for the use of the system in the ablation of benign bone tumours such as osteoid osteoma and palliative treatment of metastatic malignant lesions in bone and the vertebral body.

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