FDA OKs obstructive sleep apnea nerve stimulator for pediatric patients with Down syndrome

The FDA approved an obstructive sleep apnea neurostimulation therapy for patients aged 13 years and older with Down syndrome, according to a manufacturer-issued press release.

According to an FDA Roundup news release, the Inspire II Upper Airway Stimulator system (Inspire Medical Systems Inc.), a device placed inside a patient’s body, is now approved for patients with severe OSA and Down syndrome aged 13 years and older.

This device was previously approved for patients with moderate to severe OSA aged 22 years or older in 2014 and for patients with the same OSA severity level aged 18 years or older in 2020, according to the FDA release.

The FDA release said that this nerve stimulation therapy device helps treat patients with OSA by identifying breathing patterns from within the patient’s body and opening their airways through mild stimulation to tongue nerves. Patients can control when they receive the therapy with a remote.

With this approval, adolescent patients with Down syndrome who have an apnea hypopnea index between 10 and 50 and who cannot use CPAP will be able to receive the Inspire II Upper Airway Stimulator system, according to the manufacturer-issued release.

“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, MBA, Inspire Medical System’s President and CEO, said in the release. “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 health care providers across the U.S. about the benefits of Inspire therapy for children with Down syndrome.”

Reference:

• FDA Roundup: March 21, 2023. https://www.fda.gov/news-events/press-announcements/fda-roundup-march-21-2023. Published March 21, 2023. Accessed March 22, 2023.