Post-Approval Studies (PAS) Database

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

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
Clinical Trial Number(s)	NCT01963780
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 yrs<22 yrs, Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs
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

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background