In May, the U.S. Food and Drug Administration (FDA) approved a new surgical treatment option for use in patients with sleep apnea who do not respond well to traditional CPAP therapy.
The Inspire Upper Airway Stimulation device uses three implanted components controlled through a small remote to provide mild stimulation to maintain an open airway. The device’s neurostimulation generator is implanted in the chest, with a lead that stimulates a nerve running from the ear to the jaw.
The main FDA clinical trial evaluated 126 patients over 12 months at 22 medical centers across the United States and Europe. Data from the trial were submitted to the FDA in 2013. Results were published in the Jan. 9 New England Journal of Medicine.| | | Next → | Single Page