FDA Grants 510(k) Clearance to Thin-Film SEEG-Guided Radiofrequency Ablation System for Neurosurgery

The Food and Drug Administration (FDA) has granted 510(k) clearance to the OneRF Ablation System (NeuroOne, Eden Prairie, MN), according to an announcement from NeuroOne. The OneRF Ablation System produces radiofrequencies that generate heat to ablate nervous tissue for use in neurosurgery, with applications in Parkinson disease, epilepsy, dystonia, essential tremor, and other neurologic conditions. This is the first thin-film, stereoelectroencephalogram (sEEG)-guided radiofrequency ablation system to receive FDA clearance, providing a temperature-controlled environment in the neurosurgery setting. The OneRF Ablation System is expected to launch in 2024.

The OneRF Ablation System uses previously implanted electrodes to provide real-time temperature monitoring at the point of ablation with customizable radiofrequency generation, designed to provide a greater degree of control in neurosurgery. According to NeuroOne, the device is intended to simplify diagnostic and therapeutic procedures, while also potentially reducing hospital stays, number of surgeries, and adverse events.

"The FDA clearance of NeuroOne's OneRF system will provide neurosurgeons with an important new tool in the surgical management of epilepsy, with the ability to provide ablative therapy using already implanted depth electrodes used for diagnosing the epileptic focus as part of stereoEEG," said Robert E. Gross, MD, PhD, Chair of the Department of Neurosurgery at New Jersey Medical School and Robert Wood Johnson Medical School. "This may lead to improved outcomes for patients with potential for fewer interventions, and an improved therapeutic window."