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FDA approves implant device to help control epileptic seizures posted 7-28-97 Government officials have approved a new implant device that may help control seizures for the estimated 200,000 epilepsy patients in the United States who are unable to control them effectively with drug treatment or surgery. Food and Drug Administration officials approved the device July 16, less than six months after receiving an application from the manufacturer, Houston-based Cyberonics Inc. The device, called the NeuroCybernetic Prosthesis, is a battery-powered generator that sends electrical impulses to the vagus nerve in the neck. The nerve stimulates a part of the brain that controls seizures. About the size of a pacemaker, the device is implanted in the chest, with a wire tunneled under the skin to the lower neck, connecting the generator to the vagus nerve. Every five minutes, a painless, 30-second shock stimulates the nerve. Physicians program the device externally, and patients can switch off the implant or receive extra zaps on command by sweeping a special magnet over their chests. "Vagus nerve stimulators offer people with uncontrolled seizures a new type of treatment," said Bruce Burlington, director of the 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." Robert P. Cummins, president and CEO of Cyberonics, called the device "the first completely novel approach to the treatment of epilepsy in over 100 years." In clinical trials involving 196 patients, about half of the implant recipients reported a 20-percent reduction in daily seizures, and one-fourth reported more than a 50-percent reduction. In one case, the device proved 100-percent effective in preventing seizures. However, one in five patients with the implant actually experienced more seizures per day than they had before using the device. Physicians can only speculate about why stimulation of the vagus nerve doesn’t work for everyone. Some patients’ attacks may be triggered in a different portion of the brain than others. Researchers said that while some patients didn’t experience fewer seizures, they did notice the attacks were less severe. Related Site
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