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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Registry-Based Real-World Use Surveillance

General
Study Status	Study Pending
Application Number / Requirement Number	P150048 S092/ PAS002
Date Original Protocol Accepted	02/06/2026
Date Current Protocol Accepted	02/06/2026
Study Name	Registry-Based Real-World Use Surveillance
Device Name	TRIFORMIS RESILIA Tricuspid Valve
General Study Protocol Parameters
Study Design	Active Surveillance
Data Source	External Registry
Comparison Group	Historical 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	Registry-Based Real-World Use Surveillance. The surveillance will be carried out to assess the real-world performance of the TRIFORMIS RESILIA Tricuspid Valve.
Study Population	Patients implanted with the TRIFORMIS RESILIA Tricuspid Valve
Sample Size	All consecutive patients implanted with the device up to the first 3 years following commercial distribution of the device, who are entered into the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD; enrollment period).
Key Study Endpoints	The clinical data through 30 days (i.e., tricuspid regurgitation grade, left ventricular ejection fraction, all-cause readmission, and pulmonary embolism) will be collected through the ACSD. The follow-up data (including all-cause mortality, cardiovascular mortality, tricuspid valve reintervention, and all-cause reoperation) from year 1 through year 5 post-procedure will be obtained through the ACSD (for freedom from tricuspid valve reintervention and all-cause reoperation) and linkage with the National Death Index (for all-cause mortality and cardiovascular mortality).
Follow-up Visits and Length of Follow-up	5 years

Registry-Based Real-World Use Surveillance Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	10/27/2026
2 year report	10/27/2027
3 year report	10/26/2028
4 year report	10/26/2029
5 year report	10/26/2030

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