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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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New Enrollment Study


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General
Study Status Progress Adequate
Application Number P130008 / PAS002
Date Current Protocol Accepted 09/11/2017
Study Name New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this study is to obtain additional long-term safety and effectiveness data on the use of Inspire therapy in a post-market setting. In addition, this study will evaluate physician training by collecting post-operative safety outcomes
Study Population Description The study is being conducted in a post-market environment for the treatment of moderate to severe Obstructive Sleep Apnea (OSA) (15 less than or equal to AHI less than or equal to 65) in subjects 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.

Sample Size 127 patients. 10 sites for now. Since study initiation efforts began in March of 2015, 15 sites have been activated for enrollment in the study. Activated sites have IRB approval, contract/clinical study agreement in place, study team training completed, and additional site regulatory documents in place. Of the 15 activated sites, five have closed due to logistical or resource challenges.

Data Collection Safety: There are three safety endpoints included in this study.

Long-term device-related serious adverse events (SAE): This safety endpoint will assess long-term (5 years) safety via comparison of device related SAEs with a performance goal. Device-related SAEs include device explants due to device-related infection, device malfunction, lead fracture, device or lead reposition that results in surgical intervention.

Therapy-specific adverse events at 12 months: This safety endpoint will evaluate the safety of the Inspire system in the treatment of sleep apnea by evaluating procedure- and device-related AEs occurring immediately postimplant through 12 months.

Long-term (5 years) therapy-related adverse events: This safety endpoint will assess long-term safety via the description of all reported AEs, including all therapy- and procedure-related events.

Evaluation of Performance of Newly Trained Physicians: This endpoint will assess the performance of newly trained physician and will collect surgical times, post-operative pain recovery, procedure-related AEs and post-operation comments.

Effectiveness: Effectiveness endpoints will use disease-specific quality of life measures and OSA severity measures of ODI and AHI. Therapy effectiveness will be measured by the Epworth Sleepiness Scale (ESS) and the Functional Outcome of Sleep Questionnaire (FOSQ) quality of life questionnaires annually out to 5 years. Therapy effectiveness as measured by the apnea

hypopnea index (AHI) and the oxygen desaturation index (ODI) using a single in-lab PSG or two-night home sleep test at 3 years.

Epworth Sleepiness Scale (ESS) at 12 months: The ESS is a validated quality of life instrument that rates a subject’s daytime sleepiness.

The objective of this endpoint is to demonstrate an improvement at 12 months as compared to baseline

Functional Outcomes of Sleep Questionnaire (FOSQ) at 12 months: The FOSQ is a validated quality of life instrument that assesses the effect of a subject’s daytime sleepiness on activities of ordinary living. The objective of this endpoint is to demonstrate an improvement at 12 months as compared to baseline.

Oxygen Desaturation Index (ODI): Oxygen Desaturation Index (ODI) is a measure of OSA severity and is commonly used in the clinical evaluation of management of OSA. The ODI endpoint in this study will be determined by the ODI score at the 3-year follow up as compared to baseline. The objective is to demonstrate improvement at 3 years as compared to baseline.

Apnea Hypopnea Index (AHI). Apnea Hypopnea Index (AHI) is a measure of OSA severity. The objective of this endpoint

is to demonstrate an improvement of OSA severity at 3 years as compared to baseline.
Follow-up Visits and Length of Follow-up 5 years post-implant
Interim or Final Data Summary
Interim Safety Information Safety

A total of 104 adverse events (AEs) have been reported for 48 (38%) subjects, none of which were unanticipated. Of these 104 events, twenty (20) serious adverse events (SAEs) were reported in 14 subjects (11.0%), four (4) of which were procedure- or device/therapy-related in 2 (1.6%) subjects. A total of 84 non-serious adverse events (non-SAEs) were reported in forty (39) subjects (30.7%). Sixty-five (65) of these non-SAEs were classified as procedure or device/therapy-related in forty-four (44) subjects (34.6%).

Effectiveness

Of the 127 subjects enrolled and implanted, 76 have completed the first assessments for the effectiveness endpoints #1 and #2 (12-month ESS and FOSQ) and 35 have completed the 2-year endpoint. Sleep improvement is demonstrated by a decrease in score on the ESS. Table 11 presents

the results of 76 subjects, which shows that over time the patient did indeed improve as compared to baseline

Summary:

ESS: -5 (Clinically significant Improvement)

FOSQ: 3.46 (Clinically significant Improvement)
Actual Number of Patients Enrolled 127
Actual Number of Sites Enrolled 15 (10 active sites)
Patient Follow-up Rate Of the 127 subjects enrolled and implanted, 76 have completed the first assessments for the effectiveness endpoints #1 and #2 (12-month ESS and FOSQ) and 35 have completed the 2-year endpoint (46%)
Study Strengths & Weaknesses As per the PAS study protocol both the effectiveness outcomes in terms of ESS and FOSQ is clinically significant. However, FDA recommend you submit any information related to AHI and ODI at the end of 5 years.


New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/29/2014 10/30/2014 Overdue/Received
one year report 04/30/2015 04/29/2015 On Time
18 month report 10/29/2015 11/02/2015 Overdue/Received
two year report 04/29/2016 04/29/2016 On Time
30 month report 11/01/2016 11/01/2016 On Time
three year report 04/29/2017 05/01/2017 Overdue/Received
four year report 04/29/2018 04/26/2018 On Time
five year report 04/29/2019 04/30/2019 Overdue/Received
six year report 04/28/2020 04/24/2020 On Time
seven year report 04/28/2021    
Final Report 02/29/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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