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Trilogy Transcatheter Heart Valve System

by JenaValve Technology, Inc. United States EUDAMEDPMAGUDID

PMA P250024Ref TRILOGY-THV-L, TRILOGY-THV-M Product code NPTEMDN P070301010101

Overview

The Trilogy Transcatheter Heart Valve System is a percutaneously delivered aortic valve prosthesis designed to treat symptomatic, severe native tricuspid aortic valve regurgitation. It is indicated for patients who are determined by a Heart Team to be at high or greater risk for traditional surgical aortic valve replacement, specifically those with a predicted surgical mortality risk of 8% or higher at 30 days.

This system is intended for use by physicians experienced in transcatheter aortic valve replacement who have completed the required professional training program. The procedure must be performed under fluoroscopic guidance in a setting where emergency cardiac surgery is available. The device is subject to specific sizing requirements and must not be used if the sterile packaging is compromised or the expiration date has passed.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850000898127 UDI-DIDate25 Mar 2026ListedStatusIn distribution
United StatesFDA PMAAPPR PMA Approved NumberP250024 Date17 Mar 2026ApprovedStatusActive
European UnionCE/MDD PMA Number— Date—StatusNot known

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Not known
  • United States FDA PMA Active

Certificates: none listed in EUDAMED

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0134-2027 FDA Not yet classified initiated 31 Jul 2026
    • Ongoing Z-0136-2027 FDA Not yet classified initiated 31 Jul 2026
    • Ongoing Z-0135-2027 FDA Not yet classified initiated 31 Jul 2026

    Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

Specification

EUDAMED · PMA · GUDID · synced 23 Oct 2026

Trade Name
Trilogy Heart Valve EUDAMED
Trilogy Transcatheter Heart Valve System PMA
Trilogy Transcatheter Heart Valve GUDID
Generic Name
Aortic valve, prosthesis, percutaneously delivered PMA
Aortic transcatheter heart valve bioprosthesis, stent-like framework GUDID
Device Name
Trilogy Heart Valve Size 27
Trilogy Heart Valve Size 25
Model / Ref / Catalog
TRILOGY-THV-L, TRILOGY-THV-M
Primary DI / UDI-DI
00850000898127, 00850000898219, 00850000898110
Basic UDI-DI
B-00850000898127, B-00850000898219, B-00850000898110
PMA Number
FDA Product Code
NPT
EMDN Code
P070301010101 Stented aortic biological valves for surgical implant - valve tissue of animal origin
GMDN Term
Aortic transcatheter heart valve bioprosthesis, stent-like framework
Device Class
Class III
Market of Registration
Germany
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldPMAGUDID
Generic NamePMA
Aortic valve, prosthesis, percutaneously delivered
GUDID
Aortic transcatheter heart valve bioprosthesis, stent-like framework

From the manufacturer

The Trilogy valve is the only valve specifically designed for patients with aortic regurgitation.

Source: jenavalve.com

Other devices from JenaValve Technology, Inc.

See all devices from JenaValve Technology, Inc. →

Questions

  • Who is the intended patient for the Trilogy Transcatheter Heart Valve System?

    The system is indicated for patients with symptomatic, severe native tricuspid aortic valve regurgitation who are assessed by a Heart Team to be at high or greater risk for surgical aortic valve replacement.

  • What training is required to use this device?

    Only physicians who have successfully completed the JenaValve Professional Education training program and are experienced in transcatheter aortic valve replacement procedures are authorized to use the system.

  • Can the Trilogy Transcatheter Heart Valve System be used in any clinical setting?

    No, the procedure must be conducted under fluoroscopic guidance in a facility where emergency cardiac surgery can be promptly performed if necessary.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Animal Tissues
  • Prescription Use
  • HCT/P
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (13)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • Premarket Exempt: No
  • Lot / Batch Number: No

Sources (7)

  • FDA PMA P250024 23 fields · synced 22 Oct 2026
  • EUDAMED 00850000898127|B-00850000898127 61 fields · synced 8 Jul 2026
  • EUDAMED 00850000898219|B-00850000898219 61 fields · synced 13 Jul 2026
  • EUDAMED 00850000898110|B-00850000898110 61 fields · synced 19 Jul 2026
  • FDA UDI 82867399-87a8-4465-9746-3a742125ab3d 37 fields · synced 23 Oct 2026
  • FDA UDI 9b4a29cf-27c5-4a3e-8741-1d3f21cc4c2b 37 fields · synced 23 Oct 2026
  • FDA UDI 7be3b017-6cba-4885-a041-71be2be55cf4 37 fields · synced 23 Oct 2026