CE Mark for AspireSR™ Generator Means Automatic VNS Therapy® when Seizure Predicted

Cyberonics, Inc. has gained CE Mark approval for its AspireSR™ generator, the novel sixth-generation Vagus Nerve Stimulation (VNS) Therapy generator.


AspireSR generator technology is based on a growing body of evidence that seizures are often accompanied by an increase in heart rate (ictal tachycardia). The theory goes that by analysing relative heart rate changes, VNS therapy can be better timed to coincide with the clinical onset of seizures. Cyneronics’ proprietary technology enables the AspireSR generator to analyze heart rate and automatically respond to seizures. While currently patients can use a hand-held magnet to activate VNS manually when they anticipate the onset of a seizure, the newly approved system 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.

Physician comments

“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.”

Company comments

“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.”

Source: Cyberonics, Inc., PR Newswire

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