From the FDA:
Product Name: Inspire® Upper Airway Stimulation (UAS)
PMA Applicant: Inspire Medical Systems, Inc.
Address: 5500 Wayzata Blvd. Suite 1600
Golden Valley, MN 55416 US
Approval Date: April 14, 2020
Approval Letter: Approval Order
What is it? The Inspire® Upper Airway Stimulation (UAS) system is an implantable nerve stimulator used to treat moderate to severe obstructive sleep apnea (OSA). The Inspire® UAS system consists of implanted components including the implantable pulse generator (IPG), stimulation lead, and sensing lead and external components such as the physician programmer and the patient programmer.
This approval expands the indications for use of the Inspire® UAS in patients between the ages of 18 and 21 with moderate to severe OSA who:
Do not have complete blockage of the upper airway
Are not able, or not effectively treated by, the removal of tonsils and other soft tissue behind the nose
Have been confirmed to fail, or cannot tolerate, PAP therapy despite attempts to improve compliance
Have followed standard of care in considering all other alternative/adjunct therapies
What will it accomplish? One hundred twenty-six (126) patients participated in a clinical study across 22 investigational sites to support the original approval of Inspire® UAS. Inspire® UAS therapy provided the majority of patients with clinically meaningful reductions in the severity of their obstructive sleep apnea and improvements in their quality of life. More than half of all patients were considered responders to Inspire® UAS therapy, experiencing at least a 50% reduction in AHI and an AHI of less than 20 events per hour at the 12-month endpoint. Inspire® UAS therapy responders also experienced at least a 25% reduction in oxygen desaturation index (ODI), a scale used to indicate the severity of sleep apnea. The results of this study in addition to a small clinical study in pediatric patients with Down Syndrome provided support for expanding the indications to include older adolescents between the ages of 18 and 21.
When should it not be used? The Inspire® UAS system should not be used for the following:
Types of apnea (central and mixed) other than obstructive are more than 25% of the total AHI
Any physical finding that would compromise the performance of upper airway stimulation, such as the presence of complete blockage of the upper airway
Any condition or procedure that has compromised neurological control of the upper airway
Patients who are unable or do not have the necessary assistance to operate the sleep remote
Patients who are pregnant or plan to become pregnant
Patients with an implantable device that may be susceptible to unintended interaction with the Inspire® system. Consult the device manufacturer to assess the possibility of interaction.
Patients who require magnetic resonance imaging (MRI) other than what is specified in the MR Conditional labeling
So they approved this implantable device, which will prevent patients from having MRI diagnostic procedures for kids 18-21 after a 'study' of 126 patients.
https://www.fda.gov/medical-devices/recently-approved-devices/inspirer-upper-airway-stimulation-p130008s039