Medtronic has secured FDA clearance to market its OsteoCool RF Ablation System as a palliative treatment for metastatic bone tumors. The FDA nod positions Medtronic to expand use of a device it acquired through a deal with Baylis Medical late in 2015.
When Medtronic bought the OsteoCool System, Baylis had recently gained 510(k) clearance to sell it for use against malignant lesions in vertebral bodies. Medtronic has marketed the device for use in this indication for 13 months, in which time it has worked with Baylis to gain FDA approval to go after tumors in bones in other parts of the body such as the ribs, sacrum, extremities and hip. The latest FDA decision is the successful culmination of these efforts.
“Patients with metastatic bone cancer may be treated with conventional therapies such as opioids, chemotherapy or radiation therapy for pain palliation," the Vascular Institute of Virginia’s Sandeep Bagla said in a statement. "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."
The device is designed to provide pain relief to cancer patients with bone metastases for whom the standard therapies listed by Bagla are unsuitable or ineffective. Like other ablation systems, OsteoCool uses high-frequency energy to destroy bone tumors. The standout feature of the temperature-controlled device as compared to other ablation systems are the dual probes, a feature Medtronic sees supporting simultaneous treatment of adjacent levels.
Medtronic has listed OsteoCool as a key driver of the performance of its spine and pain units in recent quarters, in part because sales of the device boost demand for its balloon catheter products.
The expanded indication positions Medtronic to continue generating a return on the undisclosed amount it paid to acquire the technology. But, while the FDA nod opens up multiple new avenues for use of the device, the label is still more restrictive than that the OsteoCool System enjoys in the European Union. The CE mark allows for use of the device to ablate benign bone tumors, such as osteoid osteoma.