BEIJING, June 19 (Xinhuanet) -- It worked for
Superman, so on Wednesday the U.S. Food and Drug Administration approved a
medical device tested about five years ago on actor Christoper Reeve to help him
breathe without a ventilator.
The NeuRx DPS RA/4 Respiratory Stimulation System is an implantable device developed by Synapse
Biomedical Inc. of Oberlin, Ohio. It electrically stimulates the muscles and
nerves that run through the diaphragm, allowing some spinal cord injury patients
to breathe for at least four hours a day without a mechanical ventilator.
Reeve was paralyzed from the neck down in a horseback
riding accident in 1995. The "Superman" star received the experimental device in
2003 and could breathe off a ventilator for about 15 minutes while using it. He
died in 2004.
"While the NeuRx RA/4 does not cure paralysis of the
diaphragm, allowing patients to be free from a mechanical ventilator for at
least four hours a day may enhance their quality of life," said Dr. Daniel
Schultz, director of the FDA's Center for Devices and Radiological Health.
Spinal cord injuries can affect the muscles of the
chest and abdomen, including the diaphragm, which is a lower abdominal muscle
essential for breathing.
Normally, a person inhales when the diaphragm
contracts and the lungs expand with air and a person exhales when the diaphragm
relaxes and the air flows back out of the lungs.
The stimulation device uses four electrodes implanted
in the muscle of the diaphragm to stimulate contraction.
The FDA approved the distribution of the stimulation
system under a Humanitarian Device Exemption, an approval process for medical
devices intended to treat or diagnose conditions that affect fewer than 4,000
people per year.
(Agencies)