On Feb. 20, 2014, the Anesthesiology and Respiratory Therapy Devices Panel of the FDA Medical Devices Advisory Committee convened to review an application for premarket approval from Inspire Medical Systems, Inc. for the Inspire Upper Airway Stimulation (UAS) System. The Inspire II Upper Airway Stimulator is a permanently implanted device to treat moderate to severe obstructive sleep apnea. By votes of 12-0-1, the panel determined that there is reasonable assurance that the device is safe and effective, and that its benefits outweigh the risks. The panel also agreed that a continuous positive airway pressure (CPAP) therapy trial should be done before considering this device and that Inspire UAS therapy should be performed only as a second line treatment after CPAP failure. The panel’s recommendations will be taken into consideration by the FDA.
