Cyberonics Inc announced study results from The Children's Hospital at The Cleveland Clinic indicate VNS Therapy appears to be an effective and well-tolerated treatment for children with seizures due to pharmacoresistant epilepsy.

The VNS Therapy System was approved by the U.S. Food and Drug Administration (FDA) in July 1997 for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial seizures which are refractory to antiepileptic medications, but only limited data on children less than 12 years old have previously been reported.

Based upon The Cleveland Clinic results, further studies analyzing the long-term efficacy of VNS Therapy in children under 12 years of age with pharmacoresistant epilepsy appear to be warranted.

Prakash Kotagal, pediatric epileptologist at The Children's Hospital at The Cleveland Clinic, presented these findings in a poster presentation at the American Academy of Neurology conference in Hawaii on April 4, 2003.

The current study reported results from the 32 patients under 18 years of age who received VNS Therapy implants at The Children's Hospital at The Cleveland Clinic. Twelve of these 32 patients were under 12 years of age at the time of implant. Complete data were available for 27 out of 32 patients at three months post-implant. Side effects were mild and transient. At three and six months, median seizure frequency reduction was 86 percent (n=27) and 74 percent (n=21) respectively. The three-month results were statistically significant for both patients under age 12 and for patients 12 to 18 years of age. Seizure reduction remained sustained long-term at 12 and 24 months for the patients with data beyond six months.

"The results of this study indicate VNS Therapy has a positive and important role in the treatment of children and adolescents with pharmacoresistant epilepsy. Research has shown that antiepileptic medication does not provide adequate seizure control for up to 36 percent of the patient population with epilepsy," said Dr. Kotagal. "There is already an established and growing body of data supporting the use of VNS Therapy as an effective long-term treatment for pharmacoresistant epilepsy for patients over 12 years of age and we are hopeful that additional studies with long-term follow-up will demonstrate that VNS Therapy is effective in treating younger children."