|NeuroPace won an FDA panel vote for its RNS device.--Courtesy of NeuroPace|
NeuroPace is on the path to FDA approval for its anti-epilepsy neurostimulation device, winning unanimous backing from the agency's neurological devices panel.
The device, called RNS, is implanted under the skin on the skull and detects changes in brain activity that indicate oncoming seizures, delivering pulses of electrical stimulation to suppress the symptoms before they can affect patients. In a study of 191 patients, the device lowered rates of seizure by 37.9%, MedPage Today reports, good enough for an 11-0 vote from the panel. (Two members abstained from the process.)
However, some of the panelists were alarmed at the high rates of benefit in test patients whose devices were never turned on, suggesting that RNS' efficacy may not be as impressive as NeuroPace claims.
But that's not how the company is looking at the data: NeuroPace pointed out that RNS is designed to be calibrated over time by physicians, studying what rate of stimulation works best for individual patients, and the disparity of benefit between patients with and without their implants turned on grew over time, according to MedPage. After a third month of study, patients with a powered-on RNS reported a 41.5% reduction in seizures, versus 9.4% for the other group.
Regardless, the panel is recommending full approval, suggesting that NeuroPace conduct two postapproval studies if RNS wins over investigators, telling the company to follow up on efficacy rates and work to better identify the patient populations that would benefit from the device.
The FDA isn't obligated to follow the recommendations of its panels, but it often does, especially after a unanimous vote.
- read the MedPage Today story
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