American Academy of Neurology Declares Vagus Nerve Stimulation Safe and Effective.

HOUSTON--(BW HealthWire)--Sept. 13, 1999--

AAN Therapeutics and Technology Subcommittee Reassessment Says a

Preponderance of Class I Evidence Shows that VNS 

for Epilepsy is Safe and Effective

Cyberonics, Inc. (NASDAQ/NMS:CYBX) today announced that a reassessment report published in the September 11, 1999, issue of Neurology, the journal of the American Academy of Neurology (AAN), found vagus nerve stimulation (VNS(TM)) to be a safe and effective treatment for epilepsy according to a preponderance of Class I evidence. The AAN's Therapeutics and Technology Assessment Subcommittee, led by Robert S. Fisher, M.D., Ph.D. and Adrian Handforth, M.D. issued the report upon review of the results of a second major clinical study of VNS. The Subcommittee requested a reassessment due to the extensive amount of clinical research available on VNS since the original review was conducted in July of 1997.

The July 1997 review used data from a multicenter randomized study, named EO3. At that time, the Therapeutics and Technology Assessment Subcommittee concluded that VNS was a promising, but not yet established, therapy for epilepsy. The vagus nerve stimulator received approval from the United States Food & Drug Administration (FDA) in July of 1997.

A second study, named EO5, evaluated 254 patients ages 13 to 60 years old with intractable partial seizures. Following VNS implantation patients were randomly assigned to HIGH or LOW stimulation groups. The 94 patients receiving HIGH stimulation showed an average reduction in seizure frequency of 28%, compared to a 15% reduction in the patients receiving LOW stimulation. Global evaluation scores, subjective rankings by the patients on whether they are better or worse overall, were higher for the patients in the HIGH stimulation group. The cumulative results of EO3 and EO5, which included data from 310 patients, led the committee to conclude that VNS for epilepsy is effective and safe according to a preponderance of controlled scientific evidence.

"Given the importance of this novel therapy for epilepsy, and the new information provided by recent research including the EO5 study, we felt the time was right to review the committee's stance on vagus nerve stimulation," says Robert S. Fisher, M.D., Ph.D. of Barrow Neurological Institute in Phoenix, Arizona. Adrian Handforth, M.D., of West Los Angeles Veterans Affairs Medical Center, adds, "The data we reviewed was very compelling, and has been confirmed by post-approval experiences as reported in a number of journal articles and society abstracts. For many patients, VNS has not only offered improvement in seizure control but also improvement in overall quality of life."

Cyberonics, Inc. (www.cyberonics.com) was founded in 1987 to design, develop and market medical devices for the treatment of epilepsy and other debilitating neurological disorders using a unique therapy, vagus nerve stimulation. The Company's initial target market is epilepsy, the world's second most prevalent neurological disorder, which is characterized by recurrent seizures. Vagus nerve stimulation with the Cyberonics NCP(R) System was approved by the United States Food and Drug Administration on July 16, 1997, for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with medically refractory partial onset seizures. In addition to the U.S., the NCP System is currently approved for sale as a treatment for epilepsy in all the member countries of the European Union, Canada and other markets. Published research suggests that vagus nerve stimulation may improve memory and mood in epilepsy patients, and pilot studies are currently underway to determine the effectiveness of vagus nerve stimulation as a treatment for major depression.

NCP is a registered trademark of Cyberonics, Inc. VNS is a trademark of Cyberonics, Inc.