Medtronic (MDT) Receives FDA 510(k) Clearance for OsteoCool RF Ablation System

January 13, 2016 8:09 AM EST

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Medtronic plc (NYSE: MDT) announced U.S. Food and Drug Administration (FDA) 510(k) clearance and U.S. launch of the OsteoCool RF Ablation System. For physicians who treat patients with painful spine metastases, the OsteoCool System is the only cooled radiofrequency (RF) ablation technology that offers simultaneous, dual-probe capabilities - providing procedural flexibility and predictable, customized treatment. Cooled RF ablation uses targeted high-frequency energy to destroy cancer cells.

"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."

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.i Seventy percent of metastatic bone cancer patients develop at least one lesion in the spine.ii

"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."

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).

Medtronic acquired the OsteoCool technology and associated intellectual property from Baylis Medical on December 16, 2015 and partnered with the company to further innovate the system. Terms of the acquisition were not disclosed.

"We're pleased to be partnering with Medtronic to improve the treatment of patients suffering from spinal metastases," said Kris Shah, president of Baylis Medical. "Our company has a long, established track record of developing innovative clinical solutions. We are excited that this partnership with Medtronic will enhance patient access to our novel spinal tumor ablation technology."

The system is temperature controlled and uses internally water-cooled probes to prevent overheating of surrounding tissue during the procedure. The 17-gauge, bipolar probes are available in three lengths and may be used through a variety of cannula sizes. Because two OsteoCool RF ablation probes can be used simultaneously, the system supports a variety of ablation scenarios accommodating unique patient and procedural needs. The device is currently pending CE marking.

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