Neurotech s.a. Announces European CE Mark Approval for the ADNS-300 System to Treat Refractory Epilepsy
LOUVAIN LA NEUVE, Belgium, June 7, 2012 /PRNewswire/ –
Treatment of Refractory Epilepsy by Vagus Nerve Stimulation to be available in Europe
Neurotech s.a. (http://www.neurotech-int.eu), a Belgium based developer and
manufacturer of neurostimulation devices, announces 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. Operating as a pacemaker, it produces stimulation towards the brain.
“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. “Rechargeable systems may prove to be more
cost-effective, especially if surgical operations to replace batteries are avoided over
time. This helps patients to maintain a more independent life, with a lower risk of
potential complications associated with battery replacement surgery.” ‘The role of
Rechargeable Systems in Neuromodulation Paul Eldridge et al.’
“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. Early clinical testing of the device and its
different features have shown promising results (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)
The prevalence of active epilepsy is roughly in the range of 5-10 per 1.000 people
according to the World Health Organization. Approximately 1/3 of epileptic patients are
considered “refractory” and thus potential candidate for the Advens therapy.
“The commercial outlook of 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.
About Neurotech s.a. and the Advens therapy to stimulate the vagus nerve:
Neurotech s.a. is a spin-off of the Universite Catholique de Louvain (
http://www.uclouvain.be ) and has been funded by SOPARTEC (http://www.sopartec.com
), VIVES ( http://www.vivesfund.com) and SRIW (http://www.sriw.be).
Neurotech ADNS-300, its first commercial product, presents two key differentiators:
the ADNS-300 uses a rechargeable battery and the device does not only stimulate the nerve
but also records 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 should allow an improved and
personalized treatment.
Neurotech develops and manufactures its products in collaboration with a carefully
selected consortium of best-of-class European medical device manufacturers.
ADNS and Advens are filed trademarks.
SOURCE Neurotech S.A.
