HHS NEWS

P97-21                       FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE        Sharon Snider:    (301) 443-3285
July 16, 1997                
                             Consumer Hotline: (800) 532-4440


            FDA APPROVES MEDICAL DEVICE FOR EPILEPSY

     The FDA today approved the first medical device to help
reduce seizures in people with epilepsy who have severe,
uncontrolled seizures.
     The approval came just 19 days after the positive
recommendation of the Neurological Devices Panel of FDA's 
Medical Devices Advisory Committee.  FDA received an application
to market the product on Jan. 27 and expedited its review 
because of its potential importance for reducing seizures in
people who lack effective, alternative treatment.
     The device, called a vagus nerve stimulator, consists of a
generator which is implanted under the collar bone like a
pacemaker and connected by wire to the vagus nerve in the neck
where it delivers electrical signals to the brain to control
seizures.  It includes an external programming system which is
used by the physician to change stimulation settings.  Patients
can turn the stimulator on and off with a hand-held magnet by
holding it over the stimulator.
      The NeuroCybernetic Prosthesis System, made by Cyberonics,
of Houston, was approved for use in conjunction with drugs or
surgery in adults and adolescents with partial onset seizures, 
the type of seizures that begin in one part of the brain and may
remain localized or become generalized to the entire brain. 
     "Vagus nerve stimulators offer people with uncontrolled
seizures a new type of treatment," said Bruce Burlington,
director of FDA's Center for Devices and Radiological Health. 
"While this device will not help everyone, it will reduce the
frequency of seizures in many people."
     Approximately 1.7 million Americans have epilepsy.  Most
seizures can be controlled by medication.  However, about 200,000
people have seizures that cannot be fully or adequately
controlled with drugs or surgery.  Severe, ongoing seizures can
lead to death. 
     FDA's approval of the device was based on a review of
clinical studies on safety and effectiveness submitted by the
manufacturer and on the recommendation of the Neurological
Devices Panel.
     In the studies, the device was implanted in 454 patients
with poorly controlled seizures at 45 medical centers in the
United States, Canada and Europe.  The patients continued to take
anti-seizure medication during the study. 
     In the most recent study, most patients showed at least some
improvement with the vagus nerve stimulator.  Half the patients
treated had at least a 20 percent reduction in the number of
seizures per day.  In about 1 in 4, the frequency of seizures 

decreased by more than 50 percent.  In about 1 in 5, however, the
number of seizures actually increased.
     Side effects during stimulation included cough (50%),
hoarseness (100%), voice alteration (73%), and shortness of
breath (25%).  However, these side effects were considered
tolerable by most patients.
     Nine patients died during the studies, but none of the
deaths were believed by the clinical investigators to be caused 
by the device.  Four deaths were classified as Sudden Unexpected
Death in Epilepsy.  The others resulted from drownings,
pneumonia, liver failure and blood disease.
     Although the death rate was not statistically higher than
that expected for people with severe, poorly controlled seizures, 
FDA has asked Cyberonics to continue to provide detailed
information about any further deaths, particularly any sudden
unexpected deaths.  The agency has also asked the company to
further evaluate its study data to find out whether any factors
predict which patients are the most likely and least likely to
benefit from use of the device.
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