WASHINGTON (Reuters Health) Jul 03 - Neuromuscular Electrical Stimulation Systems Ltd. (NESS) has received approval from the US Food and Drug Administration (FDA) to market a neuroprosthetic device for activation of the hands in people with a C5 spinal cord injury, the privately held Israeli concern announced on Monday.
NESS said that it received FDA approval to market its Handmaster, a wrist splint-like device designed for the rehabilitation and activation of the forearm and hands.
Using integrated surface electrodes, the device delivers low-level pulses to stimulate the neuromuscular system and activate the muscles, the company explained. In clinical studies, the company added, the device was demonstrated to allow many individuals with paralysis to perform activities of daily life.
"The FDA clearance of the Handmaster is a victory for persons with spinal cord injury," stated Dr. Roger Nathan, NESS' vice president of research and development. "This device will allow many individuals with spinal cord paralysis the freedom to pour and drink from a glass, eat with a fork, write with a pen, change a diskette in a computer and perform other ordinary tasks that many of us take for granted."
"The Handmaster showed impressive results with our spinal cord injured subjects," added Dr. Gad Alon, the principal investigator and a professor of medicine at the University of Maryland School of Medicine. "After a limited amount of time, all were able to grasp, hold and release objects and perform tasks that previously were practically impossible."
The Handmaster already is available in Israel and Holland.
The company said that it hopes to begin US distribution by early 2002, after completing negotiations with several potential marketing partners.
NESS did not disclose the course of these negotiations or the names of its potential marketing partners.
But the company noted that it is
now also studying the use of its device for the return of hand functions
in stroke patients, and that it hopes to gain FDA approval for that indication
in the "not-too-distant future."
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