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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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EXPAND Continuation PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P160013 S002/ PAS001
Date Original Protocol Accepted 05/31/2019
Date Current Protocol Accepted  
Study Name EXPAND Continuation PAS
Device Name Organ Care System (OCS™) Lung System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Single-arm, prospective, observational post-approval data collection for subjects enrolled and transplanted in the Lung EXPAND clinical trial. 5-
Year follow-up data will be collected from UNOS for US transplanted patients and directly from the clinical sites in OUS patients
Sample Size All 79 subjects in the Lung EXPAND trial will be re-consented for permission to access to their follow-up data. Only patients who provide
informed consent are enrolled in the Continuation PAS.
Key Study Endpoints The primary effectiveness endpoint is Bronchiolitis Obliterans Syndrome (BOS)-free survival (freedom from BOS and mortality) through 5 years
after transplantation.
Other study endpoints include:
Survival (freedom from mortality) through 5 years after transplantation
Freedom from BOS through 5 years after transplantation
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 79 patients from the EXPAND pivotal trial
Actual Number of Sites Enrolled 8 sites
Patient Follow-up Rate 5-year follow-up rate: 98% (53/54)
Final Safety Findings There were 26 deaths and 1 retransplantation over 5 years post initial lung transplant.
Final Effect Findings 5-year rate of BOS-free survival is 55% (BOS defined as grade 1, 2, or 3)
5-year rate of patient survival is 68%
5-year rate of freedom from BOS is 76% (BOS defined as grade 1, 2, or 3)
Study Strengths & Weaknesses Despite the small sample size in this study, the long-term follow-up was high, with 5-year data collected in 53 of the 54 patients (98%) who were eligible for follow-up. These results need to be replicated in larger studies.
Recommendations for Labeling Changes Yes


EXPAND Continuation PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/29/2019 11/27/2019 On Time
one year report 05/30/2020 05/29/2020 On Time
18 month report 11/28/2020 11/23/2020 On Time
2 year report 05/30/2021 05/26/2021 On Time
final report 05/30/2022 02/22/2022 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

Additional Resources

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