Inspire OK’d for use in kids
By HME News Staff
Updated 10:11 AM CDT, Tue March 21, 2023
MINNEAPOLIS – Inspire Medical Systems has received approval from the U.S. Food and Drug Administration to offer its obstructive sleep apnea therapy to pediatric patients with Down syndrome. The approval includes patients with Down syndrome who are at least 13 years old, with an apnea hypopnea index between 10 and 50, and who do not have the ability to benefit from CPAP. “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,” said Tim Herbert, president and CEO of Inspire. “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 several years, but previously only to patients who were at least 18 years of age. Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.
Comments