Initial Clinical Experience with the First FDA-Approved sEEG-Guided Radiofrequency Ablation System Featuring Real-Time Temperature Monitoring: A Case Series.

Overview

1. Cleveland Clinic Epilepsy Center, Cleveland, OH, USA
2. Cleveland Clinic Department of Neurosurgery, Cleveland, OH, USA
3. Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH, USA

Abstract

Introduction: Stereoelectroencephalography-guided radiofrequency ablation (sEEG-RFA) has been used to create stereotactic lesions in epileptic networks. The method has been applied as a diagnostic (and at times, palliative) intervention, primarily in European epilepsy programs. To date, the technique has not been widely popularized in the USA given the lack of FDA-approved technology permitting safe usage of in situ sEEG electrodes for this purpose. Recently, the FDA approved a new hollow sEEG electrode and OneRF generator (NeuroOne) featuring real-time thermal monitoring.

Case Presentations: The authors present four illustrative, consecutive cases of refractory epilepsy patients undergoing sEEG, who underwent subsequent sEEG-RFA using the new technology. The procedure was diagnostic in all cases, with no adverse events. Importantly, all 4 patients reported decreased seizure burden following the procedure, with observed improvements informing subsequent surgical decision-making in 3 patients.

Conclusion: A new FDA-approved, hollow sEEG electrode technology permits safe sEEG-RFA lesioning, with a positive experience for both the patient and clinical team. The authors reaffirm use of this strategic technique as a diagnostic and prognostic tool, with possibility of secondary therapeutic, ablative effects. This development represents a significant advancement in the work-up of patients with intractable epilepsy, who are undergoing sEEG for invasive evaluation.

Reproduced under the paper's license (CC BY-NC), from the paper cited above.

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Data

Datasets cited

• figshare:31536907, at figshare; found in DataCite

Data Availability Statement

No datasets were generated for this case series. Clinical data are not available without additional IRB approval due to patient privacy requirements under HIPAA. Further inquiries can be directed to the corresponding author.

Reproduced under the paper's license (CC BY-NC), from the paper cited above.

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Version 1, 30 September 2026: the first record

Recorded: type, language, journal, pages, dates, 8 authors, 5 keywords, 1 funder, 17 references.

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This paper

Zavala, B., Kondylis, E., Bulacio, J., Chisholm, J., Harasimchuk, S., Rammo, R., Bingaman, W., & Serletis, D. (2026). Initial Clinical Experience with the First FDA-Approved sEEG-Guided Radiofrequency Ablation System Featuring Real-Time Temperature Monitoring: A Case Series. Stereotactic and functional neurosurgery, 1-8. https://doi.org/10.1159/000551390

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