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 Post-Approval Study

General
Study Status	Redesigned/Replaced Study
Application Number / Requirement Number	H150003 / PAS001
Date Original Protocol Accepted	04/27/2018
Date Current Protocol Accepted	10/02/2020
Study Name	Flourish Post-Approval Study
Device Name	Flourish Pediatric Esophageal Atresia Anastomosis Device
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Infant: 29 days-2 yrs
Detailed Study Protocol Parameters
Study Objectives	Study Objective and Design Objective: continued evaluation of safety and probable benefit post-approval of the Flourish device. Design: a prospective, single-arm, observational clinical study. It is a new enrollment study.
Study Population	A patient is suitable for participation in the study if the patient meets the following criteria: 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 No comparator group.
Sample Size	A minimum of 20 patients will be enrolled
Key Study Endpoints	The primary outcome measures for continued evaluation of device safety are the 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. This 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

Flourish Post-Approval Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
six month report	11/10/2017	11/27/2017	Overdue/Received
one year report	05/12/2018	05/15/2018	Overdue/Received
18 month report	11/10/2018	11/09/2018	On Time
two year report	05/12/2019	05/10/2019	On Time
three year report	05/11/2020	05/05/2020	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