FDA OKs medical implant device for epilepsy
July 16, 1997
Web posted at: 8:45 p.m. EDT (0045 GMT)
WASHINGTON (CNN) -- The Food and Drug Administration on Wednesday approved the first medical device for the treatment of epilepsy.
The device, called a vagus nerve stimulator, is designed to prevent the seizures that epileptics often have.
Between 1.7 million and 2 million Americans suffer from epilepsy. Most who have seizures can control them with medication or surgery.
However, 15 percent to 20 percent of epileptics either suffer seizures so severe they don't respond to treatment, or they can't tolerate the side effects of medication, according to the Epilepsy Foundation of America,
The vagus nerve stimulator is similar to a pacemaker. It delivers intermittent electrical pulses 24 hours a day through a generator that is implanted under the collarbone, and delivers electrical signals to the brain through a wire that is connected to the vagus nerve in the neck.
These signals control seizures. When a patient senses a seizure coming on, he can activate the stimulator to deliver an additional dose of stimulation by moving a hand-held magnet over the area of the implanted device.
The device, which is suitable for adults and children over age 12, is made by Cyberonics, a Texas-based company.
"This is a very encouraging step for people who are desperately searching for ways to control their seizures," said Ann Schear of the Epilepsy Foundation.
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