Belgium-based Neurotech has received CE Mark approval for its ADNS-300 system to treat refractory epilepsy.
The surgically implanted ADNS-300 system operates as a pacemaker to produce stimulation towards the brain by delivering mild electrical pulses to the vagus nerve in the neck.
Neurotech CEO Michel Troosters said the medical device will prove to be an important tool in the care of patients suffering from refractory epilepsy.
"The sensing feature, once clinically validated, could represent a paradigm shift in the VNS field," Troosters added.
The ADNS-300 stimulator is used in 'Advens therapy' as a therapeutic option for patients who are refractory to anti-epileptic drugs and are not eligible for epilepsy surgery.
Neurotech ADNS-300, which uses a rechargeable battery, does not only stimulate the nerve but also records neural activity from the left vagus nerve using a cuff electrode.
Physicians can leverage the sensing feature to take into account the compound action potential (CAP) generated by the stimulation, thereby allowing an improved and personalised treatment, the company said.
A remote controller and charger can be used by the patients to switch the system on and off and to recharge the neurostimulator.
The company expects to launch the new product with a steady roll-out to most European countries.