Inspire Medical Systems Gains FDA Approval for Pediatric Patients with Down Syndrome

Inspire Medical Systems, developer of minimally invasive solutions for obstructive sleep apnea (OSA), has earned U.S. Food and Drug Administration (FDA) approval for its Inspire therapy for pediatric patients with Down syndrome.
 
“Since our first FDA approval in 2014, the research team at Mass Eye and Ear, led by Dr. Christopher Hartnick, have pioneered the use of Inspire in this important group of people and we are thrilled to announce this most impactful approval on World Down Syndrome Day,” Tim Herbert, president and CEO of Inspire told the press. “We acknowledge and appreciate the persistence of Dr. Hartnick’s team, as well as the teams at the many participating institutions, to collect the necessary clinical evidence to support the FDA approval. We would also like to thank the LuMind IDSC Down Syndrome Foundation for their support of our FDA application. Inspire intends to immediately begin educating healthcare providers across the U.S. about the benefits of Inspire therapy for children with Down syndrome.”
 
Inspire has been prescribed to adults with Down syndrome for years, previously only to those at least 18 years of age. The approval now covers OSA patients at least 13 years old with an apnea hypnopea index between 10 and 50 without the ability to benefit from CPAP.
 
“When the first study of this device was published on adults, I realized it could potentially help kids with Down syndrome,” said 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.”