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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Flourish Real-World Evidence PAS

General
Study Status	Delayed
Application Number / Requirement Number	H150003 / PAS002
Date Original Protocol Accepted	10/02/2020
Date Current Protocol Accepted
Study Name	Flourish Real-World Evidence PAS
Device Name	Flourish Pediatric Esophageal Atresia Anastomosis Device
General Study Protocol Parameters
Study Design	Prospective & Retrospective Study
Data Source	Other Data Source
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Infant: 29 days-2 yrs
Detailed Study Protocol Parameters
Study Objectives	Objective: Continued evaluation of safety and probable benefit after approval of the Flourish device Design: A single-arm, RWE observational study with both prospective and retrospective data collection from patients’ medical records.
Study Population	Patients meeting the following criteria are eligible for participation in the study: 1. Has esophageal atresia (EA) 2. Atretic gap < 4cm 3. Absence of, or repaired tracheoesophageal fistula (TEF) 4. Less than 1 year of age 5. Absence of visible teeth 6. Gastrostomy tract properly sized to accommodate an 18 Fr gastric catheter 7. Absence of gastrostomy site signs of significant infection (significant as determined by physician) 8. Parent or guardian of patient provides informed consent for use of data There is no comparator group in this study.
Sample Size	A minimum of 20 patients will be enrolled.
Key Study Endpoints	Primary outcome measures for continued evaluation of device safety are rates of the following: • Stricture at the anastomotic site leading to the need for dilation or surgery • Peri-anastomotic leaks • Other adverse events and/or complications possibly, probably, or causally related to the device or procedure The secondary outcome measure for evaluation of probable benefit is successful anastomosis formation, which is defined as creation of a lumen connecting the upper esophageal pouch to the lower esophageal pouch. Per the IFU, successful anastomosis formation is confirmed by showing connected flow of contrast agent.
Follow-up Visits and Length of Follow-up	2 years after Flourish treatment There are no prespecified follow-up visits for this study, as patients will be cared for according to the physician’s clinical judgment. Data will be extracted from the medical record through 24 months and will be allocated into intervals of 2 weeks, and 1, 3, 6, 12, 18, and 24 months or until study exit.
Interim or Final Data Summary
Actual Number of Patients Enrolled	21
Actual Number of Sites Enrolled	12
Patient Follow-up Rate	N/A

Flourish Real-World Evidence PAS Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
six month report	04/02/2021	04/01/2021	On Time
1 year report	10/02/2021	10/04/2021	Overdue/Received
18 month report	04/02/2022	04/01/2022	On Time
2 year report	10/02/2022	09/28/2022	On Time
30 month report	04/02/2023	03/30/2023	On Time
3 year report	10/02/2023	09/28/2023	On Time
final report	02/29/2024	02/29/2024	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