Inspire 4063 - Clinical Summary; Stimulation Therapy for Apnea Reduction (STAR) Clinical Trial; Patients Studied

36 English Inspire System Models 3024, 4063, 4323
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
Clinical Summary
Stimulation Therapy for Apnea Reduction (STAR) Clinical Trial
The Inspire Upper Airway Stimulation (UAS) system was evaluated in a multicenter trial at study
centers in the United States and Europe for the indication of moderate to severe obstructive
sleep apnea (OSA) in patients who were not effectively treated by continuous positive airway
pressure (CPAP).
Patients Studied
The study enrolled 929 OSA patients. These patients were evaluated against patient selection
criteria that included moderate to severe OSA, a BMI (body mass index) less than or equal to
32, and the absence of a complete concentric collapse at the level of the soft palate. Following
the evaluation period, 126 patients met all selection criteria and proceeded to implant. All 126
implant procedures were successful, and 124 of the 126 implanted patients provided evaluable
data through at least 12 months. The STAR trial was an intent to treat study. Therefore, the 2
patients who did not provide evaluable data through 12 and 18 months post-implant are
assumed to be non-responders and were included in the evaluation as such. The patient
demographics for the STAR trial are included in Table 3. The patients' baseline AHI showed a
mean of 32.0 and a median of 29.3, and the baseline ODI showed a mean of 28.9 and a median
of 25.4.
Table 3. STAR Trial Subject Demographics
Continuous Measures Mean
N = 126
Median
Age, year 54.5 55
Body Mass Index, kg/m2 28.4 29.2
Neck Size, cm 41.2 41.9
Systolic BP, mmHg 128.7 128
Diastolic BP, mmHg 81.5 80.5
Male 105 (83%) Total N = 126
Race
Caucasian
African American
Hispanic
Asian
Others*
122 (97%)
0 (0%)
1 (1%)
1 (1%)
2 (2%) * 1-Surinam, 1-Turkey