Cyberonics, Inc. (NASDAQ: CYBX) announced today the CE Mark (Conformité Européenne) approval in Europe for the AspireSR generator, the novel sixth-generation VNS Therapy generator.
The AspireSR generator provides the well-established benefits of VNS Therapy, coupled with a new feature – Automatic Stimulation in response to detection of a seizure. Proprietary technology enables the AspireSR generator to analyze relative heart rate changes to detect and respond to seizures. This technology is based on a growing body of evidence that seizures are often accompanied by an increase in heart rate (ictal tachycardia). With the Automatic Stimulation feature, the AspireSR generator better aligns stimulation with the clinical onset of a seizure.
Currently, patients experiencing VNS Therapy can use a hand-held magnet to activate stimulation manually when they anticipate the onset of a seizure. This on-demand stimulation has been shown to stop or shorten a seizure, reduce seizure severity, and improve or shorten the postictal (post-seizure) recovery period. The Automatic Stimulation feature of the AspireSR generator may benefit patients who experience seizures accompanied by ictal tachycardia and are unable to perform on-demand stimulation with the hand-held magnet, do not have a magnet available when needed, or experience a seizure while sleeping.
Results of the E-36 clinical study, which evaluated the performance and safety of the AspireSR generator, were presented at the American Epilepsy Society meeting in December 2013. The study met its primary performance endpoint, and the safety profile for the AspireSR generator is consistent with currently available VNS Therapy systems.
"A significant number of people living with refractory epilepsy experience heart rate changes during their seizures," stated Prof. Dr. med. Christian E. Elger, FRCP, Head of the Department of Epileptology at the University Hospital of Bonn, Germany. "AspireSR builds upon the VNS Therapy platform by providing a unique, innovative possible therapeutic option for these patients by automatically detecting and responding to seizures upon heart rate increase."
"European approval of the AspireSR generator represents an important milestone in Cyberonics' ongoing commitment to provide technologically-advanced, device-based solutions for people with epilepsy," said Dan Moore, President and CEO of Cyberonics. "This new generator will be particularly helpful to VNS Therapy patients who are unable to use magnet-activated stimulation consistently. We believe the Automatic Stimulation feature will continue to advance VNS Therapy as a foundational therapy for people with refractory epilepsy."