CE Mark Approval For World’s First Rechargeable Vagus Nerve Stimulator To Treat Refractory Epilepsy

In short

Belgium based Neurostimulation device expert Neurotech S.A., has announced that it has obtained the European CE Mark for its ADNS™-300 system dedicated to the treatment of refractory epilepsy. The surgically implanted ADNS-300 system delivers mild electrical pulses to the vagus nerve in the neck which is clinically proven to be effective in the management of refractory epilepsy and severe depression.

Background

The prevalence of active epilepsy is in the range of 5-10 per 1.000 people according to the World Health Organisation. Approximately 1/3 of epileptic patients are considered “refractory” and thus potential candidate for the Advens™ therapy according to Neurotech.

So-called “Advens™ therapy” uses the ADNS-300 stimulator as a therapeutic option for those patients who are refractory to anti-epileptic drugs and are not eligible for epilepsy (brain) surgery.

The ADNS-300 is the world’s first rechargeable neurostimulator for vagus nerve stimulation. The device includes an innovative electrode and a promising “sensing” feature that may prove to be a significant technological breakthrough in the control of response to the therapy. Patients use a remote controller and charger to turn the system on/off and to recharge the neurostimulator.

Neurotech is a spin-off of the Université Catholique de Louvain in Louvain La Neuve in Belgium. ADNS-300, its first commercial product is differentiated by using a rechargeable battery and secondly by not only stimulating the nerve but also recording neural activity from the left vagus nerve using an innovative cuff electrode. This unique sensing feature enables the physician to capture the “compound action potential” (CAP) generated by the stimulation, which the company expects should allow for improved and personalised treatment.

Early clinical testing of the device and its different features have shown promising results*

Company comments

“We are pleased to have reached this key milestone in the development of our range of our proprietary products and we are looking forward to make this therapy available to all the eligible patients of key European centers of excellence,” said Mr. Michel Troosters, CEO of Neurotech S.A.

“We are convinced that this unique, state-of-the-art medical device will prove to be an important tool in the care for patients suffering from refractory epilepsy. The sensing feature, once clinically validated, could represent a paradigm shift in the VNS field,” added Mr. Troosters.

“The commercial outlook for Neurotech is very attractive in Europe with diversified applications in the product pipeline. We are now ready to open the capital of the company to new investors who will position Neurotech as the world-class neuromodulation company,” according to Mr. Philippe Durieux, CEO of Sopartec and board member of Neurotech. The market launch of this new product is scheduled with a gradual roll-out to most European countries.

SOURCE Neurotech S.A.

Reference: *El Tahry R, Raedt R, Mollet L et al, A novel implantable vagus nerve stimulation system (ADNS-300) for combined stimulation and recording of the vagus nerve. Epilepsy Res 2010;92:231-9)