Inspire Medical gets FDA nod for Inspire therapy's use in children with down syndrome
Iryna Drozd
- The U.S. Food and Drug Administration (FDA) gave approval to Inspire Medical Systems (NYSE:INSP) to offer Inspire therapy to pediatric patients with Down syndrome.
- The company said Inspire has already been in use for adults patients at least 18 years of age with Down syndrome for several years.
- Approval of the pediatric population with Down syndrome, will include patients with obstructive sleep apnea (OSA) who are at least 13 years old, with an apnea hypopnea index between 10 and 50, and do not have the ability to benefit from CPAP, according to the company.
- "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 President and CEO Tim Herbert.
- Down syndrome is a condition in which a person has an extra full or partial copy of chromosome 21. The disorder usually causes learning disabilities, heart and gastrointestinal disorders, among other symptoms.
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