The Food and Drug Administration (FDA) has expanded the approval of Inspire therapy to include pediatric patients 13 years of age and older with Down syndrome who have obstructive sleep apnea (OSA) with an apnea hypopnea index between 10 and 50, and do not have the ability to benefit from continuous positive airway pressure (CPAP). Previously, the therapy was only approved for adults 18 years of age and older.
Inspire therapy is a fully implanted neurostimulation device that consists of a small generator, a sensing lead, and a stimulation lead. The device is placed under the skin of the neck and chest during a same-day, outpatient procedure. The device senses breathing patterns and mildly stimulates key airway muscles to keep the airway open during sleep.
The safety and effectiveness of Inspire was evaluated in a clinical trial that included 42 patients with Down syndrome and persistent severe OSA (ClinicalTrials.gov Identifier: NCT02344108). Findings showed that upper airway stimulation was safely performed in these patients and resulted in high rates of response and improved quality of life.
“When the first study of this device was published on adults, I realized it could potentially help kids with Down syndrome,” said study investigator Dr Christopher Hartnick, Director, Pediatric Airway, Voice, and Swallowing Center in the Division of Pediatric Otolaryngology at Mass Eye and Ear in Boston. “Through the years, we have been able to leverage the technology and lead a series of clinical trials that have provided the necessary safety and efficacy data to gain the FDA approval. This is a very important step in our treatment pathways for these children who are disproportionately impacted by obstructive sleep apnea and have few treatment options.”
- Inspire Medical Systems, Inc. announces FDA approval for pediatric patients with Down syndrome. News release. Inspire Medical Systems, Inc. Accessed March 21, 2023. https://www.globenewswire.com/news-release/2023/03/21/2631228/0/en/Inspire-Medical-Systems-Inc-Announces-FDA-Approval-for-Pediatric-Patients-with-Down-Syndrome.html.
- Yu PK, Stenerson M, Ishman SL, et al. Evaluation of upper airway stimulation for adolescents with Down syndrome and obstructive sleep apnea. Published online April 21, 2022. JAMA Otolaryngology-Head & Neck Surgery. doi:10.1001/jamaoto.2022.0455