-- Scott Roberts
FRIDAY, Nov. 15, 2013 (HealthDay News) -- A device implanted
within the skull to help reduce the frequency of epileptic seizures
has been approved by the U.S. Food and Drug Administration.
The RNS Stimulator is placed under the scalp and sends
electrical pulses to the part of the brain where seizures are
suspected to originate, the agency said in a news release.
Epilepsy, estimated to affect nearly 3 million people in the
United States, is the third most common neurological disorder
behind Alzheimer's disease and stroke. Some 40 percent of those
treated for epilepsy continue to have seizures, the FDA said.
Approval for the new device was based on clinical studies
involving 191 people with drug-resistant epilepsy. Three months
after the device was implanted, participants had about 38 percent
fewer seizures per month compared to a 17 percent decrease in
seizures among people who had the implanted device turned off, the
FDA said. The most common adverse reactions included implant site
infection and premature battery discharge.
People who have had the device implanted cannot have magnetic
resonance imaging (MRI) or similar procedures, which could lead to
permanent brain damage, the FDA noted.
The RNS Stimulator is produced by Neurospace Inc., based in
Mountain View, Calif.
For more about
epilepsy, visit the U.S. National Institute of Neurological Disorders and Stroke.
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