Sam Brusco, Associate Editor06.25.24
NeuroOne Medical Technologies announced its OneRF ablation system was recently used at a Jacksonville, Fla. hospital to successfully complete five ablations in one patient.
This patient was afflicted with multifocal epilepsy, where seizures are triggered from multiple brain areas. Ten Evo sEEG electrodes were placed in various locations of the patient’s brain. Four of those electrodes identified the problematic brain areas that were triggering the seizures.
Ablations were then done at the targeted spots using a temperature control safety feature and two of these ablation occurred at different contacts on one electrodes. The same electrodes confirmed successful ablations by post-ablation sEEG recordings that showed lack of brain activity at the tissue ablation point.
The procedure was done at the patient’s bedside, which the company said saved time and costs of conducting it in an operating room.
“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,” said Dave Rosa, CEO of NeuroOne. “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.”
The company now touts a full line of thin-film electrode tech for diagnostic brain mapping and RF ablation using the same sEEG electrode. The company’s other FDA-cleared devices include the Evo cortical and sEEG electrodes, which are used mainly to stimulate, record, and monitor the brain’s electrical activity for less than 30 days.
This patient was afflicted with multifocal epilepsy, where seizures are triggered from multiple brain areas. Ten Evo sEEG electrodes were placed in various locations of the patient’s brain. Four of those electrodes identified the problematic brain areas that were triggering the seizures.
Ablations were then done at the targeted spots using a temperature control safety feature and two of these ablation occurred at different contacts on one electrodes. The same electrodes confirmed successful ablations by post-ablation sEEG recordings that showed lack of brain activity at the tissue ablation point.
The procedure was done at the patient’s bedside, which the company said saved time and costs of conducting it in an operating room.
“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,” said Dave Rosa, CEO of NeuroOne. “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.”
More about the OneRF ablation system
The device is NeuroOne’s first with a therapeutic indication and its third FDA 510(k)-cleared device.The company now touts a full line of thin-film electrode tech for diagnostic brain mapping and RF ablation using the same sEEG electrode. The company’s other FDA-cleared devices include the Evo cortical and sEEG electrodes, which are used mainly to stimulate, record, and monitor the brain’s electrical activity for less than 30 days.