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Neurostimulator Device Approved to Treat Epilepsy
The FDA has approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.
The RNS Stimulator (Neuropace, Inc.) consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two electrodes that are placed where the seizures are suspected to originate within the brain or on the surface of the brain.
Epilepsy produces seizures affecting various mental and physical functions. Seizures happen when clusters of nerve cells in the brain signal abnormally, which may briefly alter a person’s consciousness, movements, or actions.
The FDA’s approval is supported by a 3-month randomized controlled study of 191 patients with drug-resistant epilepsy.
The study showed that by 3 months after the implanted device was turned on (active use), patients experienced a nearly 38% reduction in the average number of seizures per month, compared with an approximately 17% reduction in the average number of seizures per month in patients in whom the implanted device was turned off. At the end of 3 months, the median reduction in seizures, which reflects a more-typical patient experience, was 34% with active use and about 19% with the device turned off. During the trial, 29% of patients with an active device experienced at least a 50% reduction in the overall number of seizures, compared with 27% of those with the implanted device turned off.
The most frequent adverse events were implant-site infection and premature battery depletion.
Source: FDA; November 14, 2013.