Overview
The Inspire Upper Airway Stimulation (UAS) system is Inspire Medical Systems' breakthrough neurostimulation therapy for moderate-to-severe obstructive sleep apnea (OSA). It is the only FDA-approved implantable device proven to treat OSA in patients who cannot tolerate CPAP therapy.
The system delivers mild electrical stimulation to the hypoglossal nerve — which controls tongue movement — keeping the airway open during sleep. Patients use a small handheld remote to turn the device on before bed and off when they wake up.
More than 100,000 patients worldwide have been implanted with Inspire therapy, with landmark clinical data from the STAR trial showing 79% reduction in AHI at 5-year follow-up.
Key Technology
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Hypoglossal Nerve Stimulation
Sensing lead detects breathing effort; stimulation lead delivers precise pulses to move tongue forward and open the airway.
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Breathing-Synchronized Delivery
A separate sensing lead monitors respiratory effort and synchronizes stimulation to each breath, avoiding over- or under-stimulation.
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Patient Remote + App
Handheld remote allows patient control. Companion app (Inspire 3.0) lets patients track therapy compliance and export data to physicians.
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Long Battery Life
IPG (implantable pulse generator) battery lasts approximately 11 years at typical therapy usage before requiring a minor replacement procedure.
Indications
Moderate-to-Severe OSA (AHI 15–65)
CPAP-Intolerant Patients
BMI ≤ 40 (primary indication)
Age ≥ 22 Years
Non-Primarily Central/Mixed Apnea
Candidate selection includes drug-induced sleep endoscopy (DISE) to confirm non-concentric palatal collapse pattern — the primary anatomic predictor of response to UAS therapy.
Clinical Evidence
Pivotal RCT
STAR Trial — 5-Year Follow-Up (Strollo et al.)
Landmark multicenter RCT showing 79% reduction in AHI, 69% improvement in ODI, and significant gains in ESS sleepiness scores at 5 years. Device response rate >75%.
Real-World Registry
ADHERE Registry (N=2,000+)
Real-world data from 75+ US centers showing AHI reduction consistent with STAR trial, with high therapy adherence (median 8.5 hrs/night) versus historical CPAP adherence data.
Meta-Analysis
OSA Cardiac Risk Reduction (2024)
Emerging evidence linking Inspire therapy with reduced MACE risk in OSA patients, driven by cardiovascular benefits of consistent nightly airway patency.
Regulatory Timeline
2014
FDA PMA approval — first-ever implantable OSA treatment
2016
CE Mark approved; European market expansion begins
2020
Inspire Gen 4 system launched; improved battery and programming
2022
MRI conditional labeling expanded to 3T full-body
2023
Inspire 3.0 patient app and remote update released
2025
100,000+ cumulative implants; reimbursement expanded across major insurers