Medtronic Says Newly Acquired OsteoCool™ RF Ablation System Now FDA Cleared

Medtronic plc has gained U.S. FDA 510(k) clearance for its recently (last month) acquired OsteoCool™ RF Ablation System, which it says is now ready to launch in the country.


Metastatic bone disease has been reported to occur in 60-80% of cancer patients, most frequently among patients with primary malignancies of the breast, prostate, liver, and lung. Seventy percent of metastatic bone cancer patients develop at least one lesion in the spine and pain from such lesions is an occupational hazard.

Medtronic’s OsteoCool System, acquired with the deal to buy Baylis Medical in December 2016,  is targeted at physicians who treat patients with painful spine metastases. Cooled RF ablation uses targeted high-frequency energy to destroy cancer cells and OsteoCool is the only such technology to offer simultaneous, dual-probe capabilities – providing procedural flexibility and predictable, customized treatment.  

Of note, in November, Medtronic received expanded indications for Kyphon Xpede® Bone Cement, which now includes clearance for the treatment of microfractures that can be caused by cancer cells breaking down bone (forming osteolytic lesions). Where indicated, the OsteoCool Bone Access Kit can be used for a subsequent, physician-directed procedure such as cementoplasty (i.e., vertebroplasty or kyphoplasty).

Physician comments

“The most common complaint associated with spine metastases is pain – it’s often progressive and significantly reduces the patient’s quality of life,” said Sandeep Bagla, MD, an interventional radiologist with the Vascular Institute of Virginia in Woodbridge, VA.

“With the OsteoCool system, I can now ablate the patient’s painful tumor with a reproducible procedure that’s appropriate for their unique anatomy.”

Company comments

“The OsteoCool System expands our Pain Therapies portfolio,” said Julie Foster, general manager and vice president of the Pain Therapies business in the Neuromodulation division, which is part of the Restorative Therapies Group at Medtronic. “Our customers treat patients with Kyphon® Balloon Kyphoplasty who also have painful spinal metastases. The OsteoCool system gives physicians a way to treat that pain in a single procedure with a familiar, minimally invasive technique.”

Source: Medtronic, plc


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