- Device
- Inspire II Upper Airway Stimulator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S093
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2022-12-16
- Decision code
- APPR
- Date received
- 2022-11-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the Inspire® Upper Airway Stimulation (UAS). The device is indicated for use to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA) (apnea-hypopnea index [AHI] of greater than or equal to 15 and less than or equal to 65). Inspire® UAS is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BPAP] machines) and who do not have a complete concentric collapse at the soft palate level.PAP failure is defined as an inability to eliminate OSA (AHI of greater than 15 despite PAP usage), and PAP intolerance is defined as:1) Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or2) Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it).Inspire® UAS is also indicated for use in patients between the ages of 18 and 21with moderate to severe OSA (15?AHI?65) who:1) Do not have complete concentric collapse at the soft palate level;2) Are contraindicated for, or not effectively treated by, adenotonsillectomy;3) Have been confirmed to fail, or cannot tolerate, PAP therapy despite attempts to improve compliance; and4) Have followed standard of care in considering all other alternative/adjunct therapies.