The Food and Drug Administration (FDA) has expanded the approval of Inspire therapy (Inspire Medical Systems) to include patients aged 18 to 21 years with moderate to severe obstructive sleep apnea (OSA) who are unable to use continuous positive airway pressure (CPAP). Previously, the therapy was only approved for patients 22 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 therapy received approval in 2014 based on data from the phase 3 STAR trial which assessed the efficacy and safety of Inspire therapy in 126 patients with OSA. Results showed that patients experienced a 68% reduction in apnea events, a 70% reduction in oxygen desaturation events, significant reductions in daytime sleepiness as measured by the Epworth Sleepiness Scale, and significant improvements in daytime functioning as measured by the Functional Outcomes of Sleep Questionnaire.
“The FDA and Inspire worked collaboratively to include the 18-21 year old population within the existing indication, and in the process, identified the key measures that could lead to making Inspire available to the teenage population,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “We will conduct additional research on the specific characteristics of OSA in the pediatric population, including continuing the ongoing clinical study for adolescents with Down Syndrome.”
For more information visit inspiresleep.com.