FDA approves medical device for epilepsy patients
A medical device to help reduce the frequency of seizures in epilepsy patients has been approved by the US Food and Drug Administration.
The RNS Stimulator, manufactured by California-based Neuropace, Inc., consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain.
“The neurostimulator detects abnormal electrical activity in the brain and responds by delivering electrical stimulation intended to normalize brain activity before the patient experiences seizure symptoms.”
Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
Epilepsy is the third most common neurological disorder, after Alzheimer’s disease and stroke. Approximately 3 million people in the United States are affected by epilepsy.
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