Myomo said today it won CE Mark approval in the European Union for its next-gen MyoPro myoelectric arm orthosis device.
Cambridge, Mass.-based Myomo develops and produces myoelectric orthotics for patients with neuromuscular disorders, including its flagship MyoPro line. The orthosis devices are non-invasive, powered braces used to support weak or deformed arms and hands to allow for functional activity.
Myomo touted the MyoPro as the only lightweight wearable device designed to restore function to paralyzed or weakened arms and hands in individuals who have suffered a stroke, spinal cord or nerve injury or other neuromuscular disability.
“The MyoPro powered brace allows individuals suffering from paralysis or stroke to perform routine daily activities. Gaining CE Mark approval is an important milestone for our Company and for the many people in Europe who will now be able to experience the benefits of MyoPro as they struggle with upper limb paralysis. We are currently working with our partner Ottobock to plan our European launch beginning in Germany. Myomo recently conducted sales and clinical training for Ottobock staff, which has begun evaluating patients for the MyoPro device. With revenue of over a billion Euros and operations in 50 countries, Ottobock is a global market leader in technical orthopedics and prosthetics,” CEO & chair Paul Gudonis said in a prepared statement.
Last month, Myomo released results from an investigator-led study of its MyoPro myoelectric orthotic, touting reduced upper extremity impairment with the use of the device.