Inspire Medical Systems (NYSE:INSP) announced today that the FDA has approved its implantable Inspire therapy for pediatric Down syndrome patients.
“Since our first FDA approval in 2014, the research team at Mass Eye and Ear [Boston], 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,” Inspire Medical CEO Tim Herbert said in a news 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 healthcare providers across the U.S. about the benefits of Inspire therapy for children with Down syndrome.”
Bringing Inspire therapy to more people with Down syndrome
Providing an alternative to CPAP and BiPAP, Minneapolis-based Inspire develops an FDA-approved, pacemaker-like, implantable neurostimulation technology. The company says it provides a safe and effective treatment for moderate to severe obstructive sleep apnea.
Doctors have prescribed Inspire therapy to adults with Down syndrome for several years. The new approval expands the coverage to people with Down syndrome and obstructive sleep apnea who are at least 13. Pediatric patients need to have an apnea hypopnea index between 10 and 50, and an inability to benefit from CPAP.
Inspire Medical said the research has been ongoing for several years. The company said many third-party payers, including Medicare, provide coverage for this population, improving a family’s access to care.
“When the first study of this device was published on adults, I realized it could potentially help kids with Down syndrome,” Hartnick said. “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.”