Cyberonics Unveils Results From E-36 Clinical Study Of The AspireSR Generator

(RTTNews) - Cyberonics, Inc. (CYBX) announced that results from the E-36 clinical study of the AspireSR generator were presented at the annual AES Meting, taking place December 6-10 at the Walter E. Washington Convention Center in Washington, D.C.

The company stated that 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 was designed to evaluate the performance and safety of the AspireSR generator and its IntelliSense cardiac-based seizure detection feature.

The study met its primary endpoint in that the AspireSR generator, with IntelliSense cardiac-based seizure detection, detected more than 80% of seizures accompanied by ictal tachycardia or heart-rate increase at a range of programmable settings. The potential false detection rates were low, the company said.