Cyberonics Announces Results from E-36 Study Of AspireSR Generator at AES

Cyberonics

announced today that results from the E-36 clinical study of the AspireSR generator were presented at the annual  AES Meeting, taking place December 6-10 at the Walter E. Washington Convention Center in Washington, D.C.   Paul Boon, M.D., Ph.D., Senior Full Professor of Neurology and Director of Ghent Institute for Neuroscience at Ghent University presented results of the study entitled, "Vagus Nerve Stimulation Triggered by Cardiac-Based Seizure Detection, A Prospective Multicenter Study," on December 7, 2013.  The study (NCT01325623) was designed to evaluate the performance and safety of the AspireSR generator and its IntelliSense™ cardiac-based seizure detection feature. Prof. Boon and clinical research colleagues at 13 other European centers implanted a total of 31 patients with the investigational AspireSR generator, which provides "normal mode" VNS Therapy augmented by seizure response stimulation.  After the implant procedure and initial stimulation adjustment period, patients were admitted to an epilepsy monitoring unit for up to five days and monitored to identify seizures and collect heart-rate data.  The study met its primary endpoint in that the AspireSR generator, with IntelliSense cardiac-based seizure detection, detected more than