Inspire Medical Systems, Inc. announced April 21 that the FDA has approved an expanded age range for Inspire therapy for obstructive sleep apnea, lowering the minimum age from 22 years to 18 years. Inspire therapy is used for the treatment of moderate to severe obstructive sleep apnea in patients who are unable to tolerate CPAP therapy or who fail to get consistent benefit from CPAP. It uses an implanted device to deliver neurostimulation to the upper airway, keeping the airway open during sleep.
In its announcement, Inspire stated that the expanded age range is the first step in making its therapy available to pediatric patients. The company plans additional research in pediatric patients who have sleep apnea, including a clinical study of adolescents with Down syndrome.
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American Academy of Sleep Medicine