NeuroPace, a neurostimulation device manufacturer based in California, announced that it had moved one step closer to approval with the United States Food and Drug Administration for its epilepsy implant. As of now, the device has received a positive review from the FDA Neurological Devices Advisory Panel.
According to expert panelists at the FDA, the company’s RNS implantable neurostimulator demonstrated efficacy and safety in clinical trials. Out of the 13 panelists, 12 voted that that the epilepsy implant demonstrated efficacy. Out of the panel, 11 members also voted that the potential benefits of the device outweigh the risks.
According to the company, the implantable epilepsy device is a first-of-kind RNS system that can help reduce "frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than 2 foci that are refractory to 2 or more anti-epileptic medications.”
The device works by continually recording brain activity before and after a “trigger event” for a seizure. Physicians can then review and record brainwave information and use it to detect patterns. The data is also uploaded to a specialized online database where it can be accessed by other qualified physicians and researchers.
The company first submitted a premarket approval application for the device in 2010. The first PMA was rejected by the FDA due to a lack of follow-up data for participants in pre-2010 clinical studies of the device. After submitting 12-month follow up data and clarifying statistical and clinical issues, the company has moved closer to full approval and commercialization.
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