OsteoCool RF Ablation System--Courtesy of Medtronic |
Medtronic ($MDT) stealthily acquired the OsteoCool RF Ablation System from Baylis Medical last month. Now, the medical device giant has launched the cooled radiofrequency (RF) ablation tech in the U.S. after it received 510(k) clearance from the FDA in November. Baylis and Medtronic have also partnered for further innovations to the system.
The OsteoCool device uses high-frequency energy to ablate metastatic spinal tumors in order to reduce patient pain. Medtronic expects that it could be useful in a procedure to treat cancer-related microfractures with its Kyphon Xpede Bone Cement that also received an expanded indication from the FDA in November.
"The OsteoCool System expands our Pain Therapies portfolio," said Julie Foster, GM and VP of the Pain Therapies business in Medtronic's Neuromodulation division, in a statement. "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 the minimally invasive Kyphon Balloon Kyphoplasty procedure, tubes are used to create small pathways into fractured bone. Orthopedic balloons are then inserted and inflated inside the fractured bone to correct its position and then that cavity is filled with bone cement.
OsteoCool system--Courtesy of Baylis |
Medtronic bought the OsteoCool tech and its associated intellectual property from Montreal-based Baylis on Dec. 16 for an undisclosed sum, but didn't disclose the deal until now.
Other marketed systems use similar technology, but OsteoCool is the only one with a capability to use dual probes simultaneously, Medtronic said. The system is temperature-controlled and uses internally water-cooled probes to prevent overheating of surrounding tissue. A CE mark is currently pending for the device.
"The most common complaint associated with spine metastases is pain--it's often progressive and significantly reduces the patient's quality of life," said Dr. Sandeep Bagla, 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."
- here are the Medtronic and Baylis announcements