Inspire System Models 3024, 4063, 4323 English 41
200-079-101 Rev A
3024EN_ch.fm 5/6/14 10:31 pm
4.625 x 6 inches (117 mm x 152 mm)
Inspire Medical Confidential
The randomized controlled therapy withdrawal study confirmed that the significant OSA
severity reduction at 12 months is attributable to the Upper Airway Stimulation therapeutic
effect. An analysis of AHI responder status relative to baseline characteristics is provided in
Table 8.
Table 8. AHI Responder Analysis of Baseline Characteristics
While the percentage of patients with prior UPPP surgery is noted to be twice as high in the
responder group as compared to the non-responder group, the observation was not statistically
significant (p-value of 0.22).
Conclusion
Upper Airway Stimulation is a safe and effective treatment for patients with moderate to severe
OSA who are not effectively treated by CPAP.
Baseline
Characteristics
Responders
N = 83
Mean % (N)
Non-responders
N = 43
Mean % (N)
Association of AHI
Response to
Baseline
Characteristics
p-value
Age 55.951.80.03
Gender (% Male) 82% 86% (37) 0.56
BMI 28.3 28.6 0.50
Neck Size 41.0 41.6 0.32
Baseline AHI 30.7 34.6 0.08
Baseline ODI 27.1 32.3 0.02
Prior UPPP (%) 20.5% (17) 11.6% (5) 0.22
Baseline FOSQ 14.7 13.6 0.059
Baseline ESS 11.2 12.3 0.22
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