A Food and Drug Administration (FDA) panel said it believes that Inspire Medical’s Upper Airway Stimulation Treatment System is safe and effective and that its benefits outweigh the risks. The 12-0-1 vote (yes, no, abstain) during a February meeting of the Anesthesiology and Respiratory Therapy Devices Panel paves the way for the obstructive sleep apnea (OSA) treatment to receive FDA approval. The implanted device is targeted toward patients who have failed CPAP and works by sensing breathing patterns and delivering mild stimulation to a patient’s airway muscles to keep the airway open during sleep.
The panel suggested that information in the labeling be included for patients in order to clarify the number of titrations that may be needed to establish a relevant clinical effect. The panel agreed that future patients would not need prior surgical procedures to address upper airway collapse (such as tonsillectomy or adenoidectomy) in order to fit the criteria for implantation with the Inspire system. The panel did not have any major concerns about side effects, which in a trial included tongue soreness, irritation/abrasion, discomfort due to electrical stimulation, mouth dryness, and mechanical pain, due to the high level of compliance of the patients in continuing to use the device.