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QUEBEC CITY, Feb. 3 /PRNewswire-FirstCall/ - Victhom Human Bionics Inc., "Victhom" (TSX:VHB), announced today that its Neurobionix division has obtained CE Mark approval for its Neurostep(TM) System, the first ever approval for a closed-loop system (CLS) used on peripheral nerves. CE Mark represents regulatory approval needed for the sale of the Neurostep(TM) in any of the Member States of the European Union.
The Neurostep(TM), a fully implantable investigational neuromodulation product designed to treat gait disorders (e.g., foot drop), is the first CLS product aimed at using the patient's own nervous system as the source for detection of intention to move and control their leg. Contrary to other systems that use surrogates such as external sensors, the Neurostep(TM) detects intrinsic muscle activities and surface sensation events from the nerve signals delivered to the spine and brain. This information is then used as the trigger for intervention through neurostimulation, as needed, to complete function. We believe that patients implanted with the Neurostep(TM) will experience remedy to their foot drop and an improved walking pattern that should contribute to give them more independent mobility and a healthier lifestyle.
CE Mark approval gives the Neurobionix division the ability to train and educate physicians in preparation for market release of the Neurostep(TM) System, which is planned for late 2009 in the European Union. The clearance to enter the European market allows the Neurobionix division to increase its market development activity by identification and education of hospitals and physicians that would introduce this new solution to patients in the most expedient manner.
"The approval of the Neurostep(TM) System marks a major milestone in the repositioning of the Neurobionix division into a full function organization that can develop and deliver products of a distinctive value for the market", said Mr. Nader Kameli, Chief O
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