BOSTON -- The FDA has okayed use of a strap-on robotic arm to help restore function to an upper-extremity disabled by a stroke, according to the manufacturer.
BOSTON, July 12 -- The FDA has okayed use of a strap-on robotic arm to help restore function to an upper-extremity disabled by a stroke, according to the manufacturer.
Myomo Inc. said the FDA approved its e100 NeuroRobotic System on the basis of clinical trials in which the device was associated with a 23% improvement in function as measured by the a stroke-disability scale. Moreover, the improvement in clinical trials included patients who had been disabled for 1.5 to 10 years following a stroke.
The company said the device uses a person's electrical muscle activity signal to automatically apply a power assist to facilitate movement of weakened muscles.
When the patient's arm muscles are properly "firing," the device helps the arm move through exercises and specific training tasks such as a grasping an object or raising the arm.
Clinical trials have not yet demonstrated any side effects or risks associated with use of the arm, the company said. Moreover, the company noted that the device "is intended for use with a medical professional," and has not been shown to be "safe or effective as a functional aid for use in the home.