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FDA Approves Diaphragm-Pacing Device
NEW YORK -- June 18, 2008 -- The US Food and Drug Administration (FDA) announced today that it approved the NeuRx RA/4 Diaphragm Pacing System (DPS), an implantable electronic device that stimulates the diaphragm and allows certain patients with spinal cord injury to breathe for at least 4 hours a day without a mechanical ventilator.
"While the NeuRx RA/4 does not cure paralysis of the diaphragm, allowing patients to be free from a mechanical ventilator for at least 4 hours a day may enhance their quality of life," said Daniel G. Schultz, MD, Center for Devices and Radiological Health, FDA, Rockville, Maryland.
The NeuRx DPS RA/4 uses 4 electrodes implanted in the muscle of the diaphragm to electronically stimulate contraction, thus allowing the patient to inhale.
The FDA approved the distribution of this device under a Humanitarian Device Exemption, an approval process for devices intended to treat or diagnose conditions that affect fewer than 4,000 people per year.
In a multicentre trial, the device has been demonstrated to be safe and to have probable benefit to the patient by allowing at least 4 hours per day of freedom from a mechanical ventilator.
SOURCE: US Food and Drug Administration
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