NeuroOne Plans to Ask FDA to Clear RF Ablation System in New Year
Implanted electrode system may help to ease tremor in Parkinson's
NeuroOne Medical Technologies announced it has successfully completed a feasibility study of its OneRF ablation system, which uses implanted electrodes to destroy targeted regions of the brain — and may help to control tremor in people with Parkinson’s disease — in animal models.
The company is planning to file an application with the U.S. Food and Drug Administration (FDA) next year seeking marketing clearance for the tech.
“We are extremely excited regarding the continued progress with the OneRF ablation system and believe it could have a significant impact in setting a new gold standard for these procedures, if successful,” Dave Rosa, CEO of NeuroOne, said in a company press release.
“We look forward to the FDA submission of the device in the second calendar quarter of 2023,” he added.
Successful testing of RF ablation system
This type of treatment is called radiofrequency (RF) ablation, and it may be used in the management of Parkinson’s and other neurological disorders.
NeuroOne’s Evo stereoelectroencephalography (sEEG) electrode technology, used to measure brain activity in people with neurological diseases, including Parkinson’s, recently was granted clearance by the FDA for use up to 30 days; the technology previously had been approved only for one day of use.
Electroencephalogram, known as EEG, has been used for decades to measure electrical activity in the brain. The new sEEG system from NeuroOne uses thin, flexible electrodes that are surgically implanted close to the brain. According to NeuroOne, its system can offer better signal clarity than other systems on the market for monitoring brain activity.
In the new feasibility study, which was led by scientists at the Mayo Clinic, in Rochester, Minnesota, the company tested its OneRF ablation system. It combines NeuroOne’s sEEG system with a proprietary RF generator.
RF ablation uses radio waves to heat up a small section of nervous system tissue, killing the cells therein. Destroying targeted regions of the brain can be used for the management of disease symptoms — for example, this procedure can be used to treat chronic pain by destroying nerve pathways that transmit pain signals to the brain.
In Parkinson’s, RF ablation can be used to perform thalamotomy and/or pallidotomy as a way to ease motor symptoms of the disease. Thalamotomy is the destruction of a brain region called the thalamus, which may help to control tremors. Pallidotomy targets a brain region called the globus pallidus interna and can be used to alleviate stiffness and uncontrolled movements.
NeuroOne’s RF ablation system also includes an accessory that can monitor and alter the temperature at which the tissue destruction is performed, and “allows clinicians to set temperature and time for each ablation,” the company stated in the release.
Jamie Van Gompel, MD, and his team at the Mayo Clinic implanted five sEEG electrodes in the brain of an animal model and performed electrical activity recordings. They then performed 10 RF ablations using different settings for temperature and time, which were confirmed by a brain MRI scan.
“This technology potentially represents a major improvement in the field, as it is the first known sEEG-guided RF system to monitor and adjust settings based on temperature throughout the ablation,” Rosa said, adding, “The addition of this feature may improve the safety of the procedure.”