FDA Approves Diaphragm-Pacing Device
Posted on: Wednesday, 18 June 2008, 09:01 CDT
The U.S. Food and Drug Administration has approved a device that stimulates the diaphragm and allows some people to breathe without a mechanical ventilator.
The FDA said the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device, is used by certain spinal cord injury patients to breathe for at least four hours a day without a ventilator.
Spinal cord injuries can cause paralysis, which can impact the muscles of the chest and abdomen, including the diaphragm -- the lower abdominal muscle essential for breathing, the federal agency said. Patients with severe spinal cord injuries who cannot control their diaphragms often need mechanical ventilation to help them breathe.
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.
NeuRx DPS RA/4 is manufactured by Synapse Biomedical Inc. of Cleveland.
Source: United Press International
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