Cyberonics receives CE Mark approval for its sixth-generation VNS Therapy generator

24 February 2014 (Last Updated February 24th, 2014 01:00)

Cyberonics has obtained the CE Mark approval for AspireSR, its novel sixth-generation VNS Therapy generator designed to analyse relative heart rate changes to detect and respond to seizures.

Cyberonics has obtained the CE Mark approval for AspireSR, its novel sixth-generation VNS Therapy generator designed to analyse relative heart rate changes to detect and respond to seizures.

The AspireSR generator is an implantable, programmable pulse generator that delivers a precise pattern of stimulation to the left vagus nerve.

It also provides the well-established benefits of VNS Therapy, coupled with a new feature, Automatic Stimulation, in response to detection of a seizure.

According to the company, this proprietary technology is based on a growing body of evidence that seizures are often accompanied by an increase in heart rate (ictal tachycardia).

"This new generator will be particularly helpful to VNS Therapy patients who are unable to use magnet-activated stimulation consistently."

With the Automatic Stimulation feature, the AspireSR generator aligns stimulation more effectively with the clinical onset of a seizure.

The device is specifically designed for patients who are unable to perform on-demand stimulation with the handheld magnet, do not have a magnet available when needed, or experience a seizure while sleeping.

University Hospital of Bonn head of the department of epileptology Germany professor Dr med Christian E Elger said a significant number of people living with refractory epilepsy experience heart rate changes during their seizures.

"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," Dr Elger said.

The E-36 clinical study demonstrated the safety and accuracy of the AspireSR generator and met its primary performance endpoint, while the safety profile for the AspireSR generator was found to be consistent with currently available VNS Therapy systems.

The study results were also presented at the American Epilepsy Society meeting in December 2013.

Cyberonics president and CEO Dan Moore said: "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."

According to GlobalData estimates, the vagus nerve stimulators market in Europe was valued at $37.2m in 2012 and is expected to grow at a CAGR of 11.7% to reach $80.6m by 2019.