FDA Seeks More Data Before OK’ing Extended Use Of Brain Electrodes
The U.S. Food and Drug Administration (FDA) has upheld its decision that the Evo stereoelectroencephalography (sEEG) electrode, designed to monitor brain activity in people with Parkinson’s disease and other neurological conditions in a minimally invasive way, cannot be marketed for long-term use until more safety data is provided.
Last year, the device received 510(k) marketing clearance for short-term use, meaning regulators deemed it a safe and effective medical device for use up to 24 hours. Its developer, NeuroOne Medical Technologies, appealed for the product to be approved for up to 30 days of use.
The FDA now says there is not enough evidence that in the long term, the device is “substantially equivalent,” or just as safe, as similar products on the market.
But the regulatory agency will allow NeuroOne to submit a new 510(k) once it provides such evidence. Specifically, NeuroOne will need to show that the subacute toxicity, or the adverse effect profile for this length of time, is at least equivalent to other products.
The company says it is in the process of collecting new data and plans to submit a special 510(k) application in August. Special 510(k) applications are processed by the FDA within 30 days, rather than a standard application’s usual 90 days.
“While the appeal decision is disappointing, we remain optimistic that the current product design and materials will successfully demonstrate substantial equivalence at the conclusion on the ongoing subacute toxicity test,” Dave Rosa, NeuroOne CEO, said in a press release. “Once completed, we intend to submit the new test data results to the FDA while referencing the previous 510(k) submission.”
Electroencephalogram (EEG) technology is used to monitor the brain’s electrical activity. It’s particularly useful for looking at brain signaling abnormalities in people with neurological conditions such as Parkinson’s or epilepsy.
While standard EEGs involve noninvasive electrical recordings from the scalp, newer approaches employ surgically implanted electrodes to reach deeper brain structures. These implantations can be invasive, expensive, and cause brain inflammation.
The Evo sEEG electrodes were designed to be thinner and more flexible than other electrodes, thereby eliminating the need for any of the skull to be removed during implantation. Instead, implanting the electrodes typically involves drilling tiny holes in the skull through which they are guided.
NeuroOne believes their electrode can record from deep in the brain at a higher resolution and with fewer inflammatory consequences than other electrodes. The electrodes can also be used to deliver electrical stimulations to the brain during surgeries, allowing doctors to monitor brain function and responses.
As the company works toward approval for the electrodes’ extended use, it will move forward with marketing the product for short-term use during surgeries.
“The Company will immediately explore the opportunity to market the device through Zimmer Biomet for intraoperative use to gain product clinical experience while we progress with the re-submission to the FDA,” Rosa said.
NeuroOne’s Evo cortical electrode, designed to record from or stimulate the brain’s surface, received FDA clearance for up to 30 days of use in 2019.
The technology could potentially be used therapeutically for neurological diseases like Parkinson’s. One application would be using the device to perform deep brain stimulation (DBS), wherein electrical impulses are used to stimulate specific regions of the brain.