f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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INSPIRE Continuation PAS

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Study Status Completed
Application Number /
Requirement Number
P160013 / PAS001
Study Name INSPIRE Continuation PAS
Device Name Organ Care System (OCS™) Lung System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives Two-arm observational study – continued follow-up of subjects enrolled in the INSPIRE trial

Study Population All U.S. patients enrolled in the INSPIRE trial in the UNOS database and all OUS patients in INSPIRE who consent to participation

Sample Size A total of 349 patients were enrolled in the INSPIRE trial (mITT population). The sponsor has committed to aproaching all these patients to participate in the study and give Informed Consent. Additionally, the UNOS database will be queried to obtain endpoint data on all US INSPIRE patients in an anonymized fashion by arm.

Key Study Endpoints BOS-free survival (freedom from BOS and mortality) through 5 years post-transplantation
Follow-up Visits and Length of Follow-up Subjects will be followed for 5 years post-transplant. Interim post-approval reports will be submitted at 6, 12, 18, 24, and 36 months after PMA approval.
Interim or Final Data Summary
Actual Number of Patients Enrolled 349 patients from the INSPIRE randomized trial
Actual Number of Sites Enrolled 17 sites
Patient Follow-up Rate 5-year follow-up rate: 99% (218/221)
Final Safety Findings There were 118 deaths and 14 re-transplantation over 5 years post initial lung transplant
Final Effect Findings 5-year BOS-free survival (BOS grade 1, 2, 3, or ungradeable) was similar in the OCS and SOC treatment arms (PP population: 53% OCS vs. 49% SOC, p-value=0.50; mITT population: 52% OCS vs. 49% SOC, p-value=0.57).
5-year patient survival was similar in the OCS and SOC treatment arms (PP population: 68% OCS vs. 65% SOC, p-value=0.84; mITT population: 67% OCS vs. 64% SOC, p-value=0.98).
5-year freedom from BOS (grade 1, 2, 3, or ungradeable) was similar in the OCS and SOC treatment arms (PP population: 67% OCS vs. 65% SOC, p-value=0.49; mITT population: 68% OCS vs. 65% SOC, p-value=0.35).
Study Strengths & Weaknesses Despite the acceptable number of patients and sites for a clinical study of this type and a high 5-year follow-up rate of 99%, it is concerning that the majority of participants were treated at a small number of sites. Of the 221 PAS patients, 124 patients (56%) were treated at 3 sites [Hanover (n=52); UCLA (n=47); and Leuven (n=25)]. This raises the concern that results of the overall trial may be driven by finding at these particular sites, thus limiting the generalizeability of the study findings to lung transplant patients at large. The PAS results need to be replicated in larger studies using real world evidence.
Recommendations for Labeling Changes Yes

INSPIRE Continuation PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/20/2018 09/21/2018 Overdue/Received
one year report 03/22/2019 03/22/2019 On Time
18 month report 09/20/2019 09/20/2019 On Time
two year report 03/21/2020 03/20/2020 On Time
30 month report 09/22/2020 09/18/2020 On Time
three year report 03/22/2021 03/18/2021 On Time
final report 03/21/2022 02/28/2022 On Time

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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