NYU Langone Medical Center Study Shows VNS Therapy Is A Safe And Effective Treatment For Refractory Epilepsy

Main Category: Epilepsy
Also Included In: Neurology / Neuroscience;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 05 Dec 2009 - 1:00 PST

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AES Annual Meeting, Booth #901-- Cyberonics, Inc. (Nasdaq: CYBX) announced that Vagus Nerve Stimulation (VNS) Therapy, the only FDA-approved implantable medical device for the treatment of refractory epilepsy, will be featured in 14 presentations at the American Epilepsy Society's (AES) Annual Meeting, taking place December 4-8 at the Hynes Convention Center in Boston, Massachusetts.

Robert Elliott, M.D., chief resident of Neurosurgery at NYU Langone Medical Center, will present results of the study entitled, "Vagus Nerve Stimulation for Refractory Epilepsy: Single Surgeon Experience of over 700 Consecutive Operations," on Monday, December 7 at 4:00 p.m. The study was designed to analyze the efficacy and safety of VNS Therapy in a large series of consecutive adults and children with medically refractory epilepsy.

Dr. Elliott and his colleagues at NYU Langone Medical Center conducted a retrospective review of 507 consecutive patients with refractory epilepsy who underwent a total of 720 VNS-related procedures between November 1997 and April 2008. Outcome analysis was performed on 436 patients who underwent primary implantation at the center and had at least one year of follow-up since implantation. Duration of VNS Therapy ranged from one week to 11.35 years.

The results showed a more than 50 percent reduction in seizure frequency occurred in 64.6 percent of patients and 42.1 percent of patients experienced more than a 70 percent reduction in seizure frequency. Patients who had failed intracranial epilepsy procedures prior to VNS Therapy had similar outcomes to those who did not have prior surgery. There were no significant differences in efficacy between adults and children.

"Our study reviewing more than 700 consecutive VNS Therapy procedures further confirms the safety and efficacy of VNS Therapy for medically refractory epilepsy," said Dr. Elliot. "Patients evaluated in this study varied in age, seizure frequency and treatment histories, and the vast majority of patients saw significant improvements in their seizure control. VNS Therapy continues to be an effective way to treat medically refractory epilepsy while possibly improving the quality-of-life for patients."

"Dr. Elliott's study reaffirms the safety, efficacy and quality-of-life benefits of VNS Therapy," said Dan Moore, president and CEO of Cyberonics. "Worldwide, more than 50,000 patients with epilepsy have received VNS Therapy, and a significant majority of these patients are consistently opting to continue treatment, which is evidenced by an initial reimplant rate that exceeds 70 percent. These findings further establish VNS Therapy as the best option for patients with medically refractory epilepsy who are not candidates for resective surgery or who have failed resective surgery."

About Cyberonics, Inc. and VNS Therapy(®)

Cyberonics, Inc. (Nasdaq: CYBX) is a medical technology company with core expertise in neuromodulation. The company developed and markets the VNS Therapy System, which is FDA-approved for the treatments of refractory epilepsy and treatment-resistant depression. The VNS Therapy System uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.

Source: Cyberonics, Inc