| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| Device | Trilogy Transcatheter Heart Valve System |
|---|
| Generic Name | Aortic valve, prosthesis, percutaneously delivered |
|---|
| Applicant | JenaValve Technology, Inc.
4 Cromwell
Irvine, CA 92618 |
|---|
| PMA Number | P250024 |
|---|
| Date Received | 06/30/2025 |
|---|
| Decision Date | 03/17/2026 |
|---|
| Product Code |
NPT |
| Advisory Committee |
Cardiovascular |
|---|
| Clinical Trials | NCT04415047
|
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
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 Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
Labeling Part 2 |
|---|
| Post-Approval Study | Show Report Schedule and Study Progress |
|---|
| Supplements: |
S001 S002 |
|
|
