FDA Expands Approval of Inspire Therapy to Include Pediatric Down Syndrome Patients

The FDA has granted expanded approval to Inspire Medical Systems’ Inspire neurostimulation device to treat pediatric patients with Down syndrome who have obstructive sleep apnea.

The Inspire device, which can be operated using a remote control, is designed to open the airways while the patient is asleep.

The neurostimulation device was previously approved for patients 18 years and older with obstructive sleep apnea (OSA).

Approval for the pediatric population with Down syndrome includes OSA patients who are at least 13 years old who cannot be effectively treated with continuous positive airway pressure therapy.