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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceTrilogy Transcatheter Heart Valve System
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantJenaValve Technology, Inc.
4 Cromwell
Irvine, CA 92618
PMA NumberP250024
Date Received06/30/2025
Decision Date03/17/2026
Product Code NPT 
Advisory Committee Cardiovascular
Clinical TrialsNCT04415047
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Trilogy Transcatheter Heart Valve System is indicated for the treatment of symptomatic, severe native tricuspid aortic valve regurgitation (not due to acute endocarditis, rheumatic heart disease, or acute aortic dissection) in patients who are judged by a Heart Team, including a cardiac surgeon, to be at high or greater risk for surgical aortic valve replacement (i.e., predicted risk of surgical mortality >=8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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