This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Inspire Upper Airway Stimulation
PMA Applicant: Inspire Medical Systems, Inc.
Address: 5500 Wayzata Blvd. Suite 1600
Golden Valley, MN 55416 US
Approval Date: June 8, 2023
Approval Letter: Approval Order

What is it?

The Inspire Upper Airway Stimulation (UAS) system is an implantable nerve stimulator used to treat obstructive sleep apnea. The Inspire UAS system includes the implantable pulse generator (IPG), stimulation lead, and sensing lead, as well as external components: the physician programmer and the patient remote.

This approval expands the indications for use to include people with obstructive sleep apnea who have an upper limit baseline apnea-hypopnea index (AHI) of 100 (increase from ≤65 to ≤100). The approval also increases the upper limit for recommended body mass index (BMI) to 40 (increase from ≤32 to ≤40).

How does it work?

The IPG detects the patient’s breathing pattern and maintains an open airway by stimulating the nerves using small electrical impulses. The doctor can program stimulation settings using the external physician programmer. The patient remote allows the user to turn on the treatment before falling asleep and turn it off when awake.

When is it used?

The Inspire UAS system is used to treat people with moderate to severe obstructive sleep apnea (15≤ AHI ≤ 100) who are age 22 and older and who:

• Are not able to use or tolerate positive airway pressure (PAP) or bi-level positive airway pressure (BiPAP) treatments according to clinical criteria that define the inability to eliminate obstructive sleep apnea or an intolerance for PAP.
• Do not have complete blockage or concentric collapse of the back, muscular part of the roof of the mouth, called the soft palate.

The Inspire UAS system is also indicated for use in people between the ages of 18 and 21 with moderate to severe obstructive sleep apnea (15≤AHI≤100) and people between the ages 13 to 18 with down syndrome and severe obstructive sleep apnea (10≤AHI≤50) who meet the criteria above and additionally:

• Are not candidates for surgery to remove the adenoids and tonsils (adenotonsillectomy). 
• Have been considered for all other alternative/additional treatments that are considered the standard of care for this condition.

What will it accomplish?

Data from the ADHERE Registry, an ongoing observational study, showed that people with an AHI greater than 65 and those with a BMI greater than 32 had outcomes consistent with those of the STAR trial. People with AHI less than or equal to 100 and those with BMI less than 40 demonstrated significant reductions in the severity of obstructive sleep apnea and improvements in quality of life.

When should it not be used?

The Inspire UAS system should not be used for people who:

• Have other types of apnea (central and mixed) besides obstructive sleep apnea make up more than 25% of the total AHI score.
• Have a physical condition that would keep upper airway stimulation from working well, such as a complete blockage of the upper airway. 
• Have any condition or previous treatment will compromise or prevent neurological control of the upper airway.
• Cannot operate the sleep remote or do not have necessary assistance to operate it. 
• Are pregnant or plan to become pregnant.
• Have another implantable device that could possibly have an unintended interaction with the Inspire system. Contact the device manufacturer to assess the possibility of interaction.
• Requires magnetic resonance imaging (MRI) other than what is specified in the MR Conditional labeling for this system. 
• Has rhabdomyolysis.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• PMA Database Entry