Thin-Film, sEEG-Guided RF Ablation System Could Transform Neurosurgery Procedures

The OneRF Ablation System from NeuroOne Medical Technologies (Eden Prairie, MN, USA) is designed for creating RF lesions in nervous tissue for functional neurosurgical procedures. NeuroOne is known for developing and commercializing advanced thin-film electrodes that serve both diagnostic and therapeutic purposes, offering a more effective approach to treating various neurological conditions. The OneRF Ablation System is poised to revolutionize surgical practices, potentially allowing patients to undergo a single surgery for both diagnostic and therapeutic needs. This innovation could lead to reduced hospitalization duration, fewer surgeries, and fewer adverse events, all while providing substantial clinical advantages. The system's temperature control capability at the ablation point further enhances patient safety.

The system enables ablative therapy using depth electrodes that are already implanted for diagnosing the epileptic focus as part of stereoEEG. This development can lead to better patient outcomes, potentially requiring fewer medical interventions and offering an expanded therapeutic window. The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to NeuroOne's OneRF Ablation System, marking the company's first therapeutic device and third FDA-cleared product. The FDA approval empowers neurosurgeons with an important instrument in the surgical treatment of epilepsy. NeuroOne now offers a comprehensive range of electrode technology, catering to patients in need of diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode. Other FDA-cleared devices from NeuroOne include the Evo cortical and sEEG electrode product lines, primarily used for recording brain electrical activity for periods shorter than 30 days.

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