WEBSTER, Texas, July 16, 1997 -- Cyberonics, Inc. (NASDAQ/NMS:CYBX), announced today that the U.S. Food and Drug Administration ("FDA") has given approval to the Company to market its proprietary, implantable vagus nerve stimulation device, the NeuroCybernetic Prosthesis ("NCP System"), for the treatment of medically refractory partial onset seizures. The clearance comes less than 180 days from the time that Cyberonics submitted clinical trial data from seven studies to the FDA and less than 20 days after the FDA Advisory Panel unanimously recommended approval of the product. The NCP System, a "pacemaker for the brain" is the first device treatment option ever made available for epilepsy. The implantable device consists of a generator and a nerve stimulation electrode which transmits antiepileptic electrical signals to the brain through the vagus nerve in the neck. The device is indicated for use by the FDA "as an adjunctive treatment for adults and adolescents over 12 years of age with medically refractory partial onset seizures."
Epilepsy is the world's second most prevalent neurological disorder, affecting an estimated 50 million people worldwide. This disorder is characterized by intermittent disturbances in the normal electrical functions of the brain, known as seizures. Manifestations of a seizure include interruption or complete cessation of movement, generalized contraction of the body, decreased responsiveness, loss of awareness of surroundings and complete loss of consciousness. While seizures can be linked to identifiable injuries to the brain such as head trauma and brain tumors, the cause of nearly 70% of epilepsy cases remains unknown.
According to the Epilepsy Foundation of America ("EFA"), approximately 2.5 million Americans, or slightly less than one percent of the population, suffer from some form of epilepsy. Thirty percent of all epilepsy patients are under the age of eighteen. Approximately 53% of all epilepsy patients are being treated for partial onset seizures. Of these, one in three (approximately 425,000) is estimated by the EFA to be refractory, that is they continue to have unsatisfactory seizure control or intolerable medication-induced side effects after being treated with appropriate antiepileptic therapies for a reasonable period of time. Refractory epilepsy exacts a heavy quality of life toll on patients and their families with considerable psychological, sociological, physical and financial ramifications.
"We are delighted by the FDA's quick approval of the NCP System, the first completely novel approach to the treatment of epilepsy in over 100 years. Cyberonics was founded to develop effective alternative treatments for patients with epilepsy and we are excited about making this clinically proven, life-enhancing option available to patients with medically refractory partial onset seizures in the U.S.," said Robert P. Cummins, President and CEO of Cyberonics, Inc. "The results of clinical studies confirm the broad antiepileptic and anticonvulsant effects of vagus nerve stimulation. TodayÕs approval underscores the FDA's commitment to working with industry to rapidly review and approve innovative medical technologies founded on rigorous science and validated by extensive clinical study."
"This is the future of epilepsy treatment for hundreds of thousands of people who have not found relief from seizures using existing therapies," said Dr. Douglas Labar, M.D., Ph.D. of Cornell University's Comprehensive Epilepsy Center. "Many epilepsy patients will be able to enjoy a higher quality of life, free from the restricting symptoms of this disorder."
The NCP System is a fully implantable device, intended for patients with medically refractory partial onset seizures, that is those patients who are unable to control seizure occurrence with antiepileptic drug treatment or epilepsy surgery. Implantation of the device is accomplished during a one to two hour surgical procedure, which can be performed on an outpatient basis. Like a pacemaker, the pulse generator is implanted under the skin in the chest. The lead wire is then tunneled under the skin to the lower neck, where it is placed around the vagus nerve. Using an external programmer, the neurologist can set or reset the stimulation parameters of the device. The NCP System delivers preprogrammed intermittent electrical pulses to the vagusÑfor example, 30 seconds on, five minutes off --- 24 hours a day. Additionally, when a patient senses a seizure coming on, he or she is able to activate the system to deliver an additional dose of stimulation by passing a magnet over the area of the chest where the device resides. Many patients report that they are able to prevent or abort a seizure using the magnet.
The first human implant of the NCP System occurred in 1988. Since then more than 1,000 patients in 24 countries have accumulated over 2,000 patient years of experience using the NCP System. Results of preclinical studies, clinical trials and mechanism of action research confirm that the NCP System offers many refractory patients significant improvements in seizure control, none of the debilitating central nervous system side effects commonly associated with antiepileptic drugs and a favorable risk/benefit ratio which is maintained over time when the NCP System is used as part of a patientÕs long term treatment regimen.
"Epilepsy is a highly prevalent neurological disorder affecting more than 50 million people worldwide. For the thousands of patients with uncontrolled epilepsy, living with the unpredictability of partially controlled or uncontrolled seizures takes a toll on the individual and family. A reduction of seizure frequency can make a difference in employability, self confidence and overall well being of patients with epilepsy," noted Paulette V. Maehara, CEO of the Epilepsy Foundation of America. "We are excited about the possibilities that the NCP System represents since it is the first device treatment option for epilepsy. The NCP System may be a unique opportunity for people with epilepsy. It represents the first time a device has been developed to minimize or prevent seizure activity. If it can reduce seizure frequency and reduce the number of medications individuals are using, people with epilepsy will benefit. It also offers patients self management aspects which is so critical to people with epilepsy."