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Medtronic’s OsteoCool gets further indications from FDA

OsteoCool from Medtronic uses both AdvantageRF and AdvantageFD platforms from Energize Medical. The OsteoCool technology recently won further indications from FDA, as originally reported in MassDevice:

Medtronic (NYSE:MDT) said today that it won an expanded indication from the FDA for its OsteoCool RF ablation device for palliative treatment of metastases in all bony anatomy.

The OsteoCool RF device was previously indicated for use in the spine, according to Fridley, Minn.-based Medtronic. It’s used to ablate metastatic bone tumors. Medtronic acquired the technology when it bought Baylis Medical for an undisclosed amount back in December 2015. 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 in November 2015 for the 3rd iteration.

“Our pain therapies business is deeply rooted in the Medtronic mission – which calls us to alleviate pain,” pain therapies interventional GM Jeff Cambra said in prepared remarks. “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.”

“We’re pleased to broaden our partnership with Medtronic to improve the treatment of patients suffering from painful metastases,” added Baylis Medical president Kris Shah. “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.”

“Patients with metastatic bone cancer may be treated with conventional therapies such as opioids, chemotherapy or radiation therapy for pain palliation,” said Dr. Sandeep Bagla of the Vascular Institute of Virginia in Woodbridge. “With the expanded indication for the OsteoCool system, I now have the option to ablate these patients’ painful bone tumors when conventional therapies are considered ineffective, too slow-acting or cause unacceptable side effects.”

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