people in Europe have clinically relevant TR5
A life-threatening condition like severe tricuspid regurgitation (TR)1 deserves a revolutionary approach†
Medications may treat symptoms but not the TR itself, which can continue to progress.3,4
of patients with mild or trivial TR progressed to moderate or severe TR in ~3 years6‡
of patients with severe TR are estimated to die within 1 year of diagnosis2,7
The EVOQUE valve has the potential to eliminate tricuspid regurgitation§
Tricuspid valve with regurgitation (left) vs. with the EVOQUE valve (right)
Move the arrow left or right to see the comparison between a heart with tricuspid regurgitation and one with the EVOQUE valve
Tricuspid valve with regurgitation (left) vs. with the EVOQUE valve (right)
Because TR can progress in severity, reducing TR severity may improve patient quality of life3,8
*First-of-its-kind device commercially available (in the EU).
†Based on US data.
‡Based on a retrospective echocardiographic analysis of Israeli patients.
§In a paired analysis of the first 150 patients in the TRISCEND II trial, 77.8% of EVOQUE+OMT patients achieved TR reduction to none/trace at 6 months follow-up (n=81).
Meet the EVOQUE system
The first-of-its-kind transcatheter tricuspid replacement option for eligible patients*
*First of its-kind-device commercially available (in the EU)
Introducing the EVOQUE valve
†No clinical data are available that evaluate the long-term impact of the Carpentier-Edwards ThermaFix tissue process in patients.
‡Excluding Edwards SAPIEN 3 Ultra RESILIA valves
A system designed with your patients in mind
A transcatheter procedure designed for ease of use
Procedural efficiency with an average device time of 65 minutes*
*Device time defined as time from delivery system insertion to delivery system removal.
Multiple valve sizes designed to treat a wide range of patient anatomies
Transfemoral 28F outer diameter delivery system designed for manoeuvrability
Low profile delivery system with 3 planes of movement designed for controlled positioning
See the clinical evidence
Data shows that the EVOQUE system has the potential to eliminate TR*
*In a paired analysis of the first 150 patients in the TRISCEND II trial, 77.8% of EVOQUE+OMT patients achieved TR reduction to none/trace at 6 months follow-up (n=81).
Data summary of first 150 patients at 6 months
The TRISCEND II pivotal trial is a prospective, global, multicentre randomised controlled clinical trial to evaluate the safety and effectiveness of the EVOQUE system with optimal medical therapy (EVOQUE + OMT) compared to OMT alone in patients with at least severe TR. These data relate to the first 150 patients randomised and treated in the TRISCEND II pivotal trial, for which follow-up is ongoing.9
The EVOQUE system effectively eliminated TR in a majority of patients
In the analysis of the first 150 patients, the TRISCEND II pivotal trial met the first co-primary effectiveness endpoint with TR grade reduction to ≤ moderate at 6 months, and 77.8% of patients achieved a TR grade of none/trace.
a Pooled Z-Test with continuity correction to be compared with one-sided significance level of 0.025.
bCumulative valvular TR rates shown above. Over 85% of patients in the EVOQUE+OMT group had none/trace PVL at 6 months. Mild PVL was reported to be 8.8% at 6 months, with moderate PVL reported to be 2.5% at 6 months. No patients were reported to have severe or greater PVL at 6 months.
The EVOQUE system demonstrated an acceptable safety profile*
In the first 150 patient cohort, the EVOQUE system demonstrated a lower MAE rate than the expected MAE rate derived from isolated tricuspid valve surgery.10
Composite Major Adverse Event (MAE) Rate†
*In an analysis of the first 150 patients in the TRISCEND II pivotal trial, 27.4% (26/95) of EVOQUE+OMT patients had major adverse events at 30 days.
†Patients have had more than 1 event.
‡MAEs from Medicare FFS Claims, Standard Analytic Files from 2011-2018 Isolated TV replacement surgery cohort, N=2036.
§Fatal, life-threatening, extensive, or major bleeding as defined by the Mitral Valve Academic Research Consortium
93.8% of patients treated with EVOQUE+OMT had mild or less TR at 6 months*
*In a paired analysis of the first 150 patients in the TRISCEND II trial, EVOQUE+OMT patients (n=81).
The EVOQUE system significantly improves functional status and quality of life outcomes
In the analysis of the first 150 patients, the TRISCEND II pivotal trial met the second co-primary effectiveness composite endpoint consisting of clinically meaningful functional and quality of life outcomes at 6 months.
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Hierarchical composite endpoint
Improvement in KCCQ Score
Improvement in NYHA Class
Increase in 6MWD
aThe lower bound of the one-sided 97.5% confidence interval is 2.6.
bKCCQ overall summary score improvement of ≥ 10 points.
cNYHA functional class improvement of ≥ 1 class.
d6MWD improvement of ≥ 30 meters.
Download resources
Get answers to your questions about the EVOQUE system and see the clinical evidence from the TRISCEND II pivotal trial.
