US-based neurology firm, NeuroOne, has announced that its OneRF brain ablation system has been used on a patient for the first ever time, with one Florida hospital successfully carrying out five ablation procedures in one patient.
Carried out in a patient living with multifocal epilepsy, a condition whereby seizures are triggered from multiple areas of the brain, the procedure involves ten electrodes being placed in various locations across the patient’s brain used to identify areas of the brain that were triggering seizures.
Stereoelectroencephalography (sEEG) measurements taken by the electrodes confirmed a lack of brain activity at the point of tissue ablation without the patient ever entering an operating room as part of the procedure, cutting operational costs and time.
The announcement follows after NeuroOne was able to successfully secure US Food and Drug Administration (FDA) 510(k) clearance for the device and a limited commercial run in March 2024. According to NeuroOne, the brain ablation market is worth at least $100m worldwide.
Dave Rosa, CEO of NeuroOne said: “It was exciting for the company to witness the first clinical ablations performed using the OneRF Ablation System. The ability to safely perform these procedures at the patient’s bedside will reduce operating room time and cost, freeing up the operating room to conduct additional procedures.
“We look forward to additional procedures utilizing the system with the goal of providing a safe therapy for patients to both monitor and ablate problematic brain tissue. In the future, the company intends to leverage the OneRF generator with future FDA submissions for additional ablation applications.” NeuroOne is set to enter a field that has already seen significant competition, with a number of companies recently gaining clearance for their own brain ablation systems ranging from smaller companies such as ClearPoint Neuro, to medical device giant Medtronic with its Accurian radio frequency (RF) ablation system.
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By GlobalData