First device for severe epilepsy

FDA Consumer, Nov-Dec, 1997

Citing the potential importance of alternative treatment for some people with epilepsy, FDA approved the first medical device to help reduce frequent, uncontrolled epileptic seizures.

The NeuroCybernetic Prosthesis System is approved for use with drugs or surgery in adults and adolescents with partial onset seizures. These seizures, which begin in one part of the brain, may remain localized or spread to the entire brain.

The July 16 approval came just 19 days after an FDA advisory panel recommended the device.

The new device has an electrical generator that is implanted under the collar bone with wires to the vagus nerve in the neck, where it delivers signals that stimulate the brain to control seizures. Doctors can change nerve stimulation settings with an external programming system, and patients can turn the device on and off by holding a magnet over it.

Approximately 1.7 million Americans have epilepsy. About 20O,000 of these patients have seizures that cannot be adequately controlled by drugs or surgery. Severe, ongoing seizures can lead to death.

Clinical studies of the device included 454 patients. In the most recent study, half the patients had at least a 20 percent decrease in the number of daily seizures, one in four had a decrease of more than 50 percent, and one in five had increased seizures. Nine patients died, but clinical investigators did not believe stimulation from the device was the cause. FDA has asked the manufacturer, Cyberonics, of Houston, to provide detailed information on any further deaths.