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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 Progress Inadequate
Application Number P160013 / PAS001
Study Name INSPIRE Continuation PAS
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 Design Description Two-arm observational study – continued follow-up of subjects enrolled in the INSPIRE trial

Study Population Description 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.

Data Collection 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.

INSPIRE Continuation PAS Schedule

Report 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    

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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