New device gains approval to help in fight against epilepsy

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A new implantable device could allow people with epilepsy to take control of their seizures.

Fox 9 reports that the NeuroPace RNS System has been approved by the Food and Drug Administration, and is available at all Mayo Clinic sites.

The company says the treatment has been effective in patients who average three or more disabling seizures a month and could help as many as 400,000 people in the United States take control of their seizures.

NeuroPace CEO Frank Fischer said, "We believe the RNS System has the potential to provide substantial improvement in quality of life to hundreds of thousands of people diagnosed with epilepsy in the United States who are unable to achieve seizure control with medications."

The system works by detecting abnormal activity in the brain and delivers subtle levels of electrical stimulation to normalize brain activity before a person suffers a seizure. It is used as an adjunctive therapy in reducing the frequency and severity of seizures.

The NeuroPace RNS System is used as an adjunctive therapy in reducing the frequency and severity of seizures in people 18 years of age or older with partial onset seizures who:

The agency conducted a 3 month randomized controlled trial of 191 patients who had drug-resistant epilepsy. After three months, the device had helped reduce the average number of seizures a month by nearly 38 percent.

Mayo Clinic participated in clinical trials and enrolled the most patients into trials. Mayo also has received research support for NeuroPace and Dr. Richard Zimmerman has been paid as a consultant and sits on the advisory board for NeuroPace.

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