On March 21, 2023, Inspire Medical Systems, Inc. announced it received FDA approval to offer Inspire therapy to pediatric patients with Down syndrome.
About Inspire therapy
Inspire upper airway stimulation is used to treat patients with moderate to severe obstructive sleep apnea (OSA) who cannot tolerate PAP treatments and who do not have a complete concentric collapse at the soft palate level.
Inspire therapy is a surgical solution. The system includes an implant that keeps the patient’s airway open while sleeping, a remote to turn on therapy when sleeping, and an app to track and share sleep data with a medical professional. The implant is placed near the patient’s collarbone during an outpatient procedure.
This latest FDA approval is for the Inspire system to be used for a subset of teenagers with Down syndrome with severe OSA who are at least 13 years old, have an apnea-hypopnea index between 10 and 50, and are unable to benefit from CPAP. Patients must not be candidates for adenotonsillectomy and they must have been considered for all other alternate treatments.
Inspire was approved for use in adult patients 22 years of age or older in 2014. In 2019, supplemental approval expanded the indication to allow patients between 18 to 21 years of age. Now, this supplement expands the indication further to include pediatric patients with Down syndrome between 13 and 18 years of age.
According to the company’s press release, Inspire therapy is the first and only FDA-approved neurostimulation technology to treat moderate to severe OSA.
About upper airway stimulation therapy
Upper airway stimulation therapy, a surgical solution for sleep apnea, involves the implantation of a device near the neck and chest that stimulates the hypoglossal nerve to keep the airway open during sleep, providing an alternative for those unable to tolerate CPAP or oral appliances.
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