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)
Learn about 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 approximately one hour
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
Superior clinical benefit and consistent TR resolution for patients with EVOQUE TTVR
The TRISCEND II pivotal trial establishes TTVR as a new treatment option for patients with symptomatic ≥ severe TR
The TRISCEND II trial is a prospective multi-center randomized controlled trial evaluating the safety and effectiveness of transcatheter tricuspid valve replacement with the EVOQUE system plus optimal medical therapy compared to optimal medical therapy alone in patients with symptomatic severe TR. These data pertain to the entire cohort of 400 patients at 1 year.
Superior clinical benefit with EVOQUE TTVR compared to medical therapy alone
The TRISCEND II trial successfully met the composite primary safety and effectiveness endpoint at 1 year.
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Composite Endpoint
Win Ratio Analysis
Consistent TR resolution in a broad patient population with EVOQUE TTVR
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TR Reduction
Treats a diverse patient population
Treats a broad patient population
*Refer to Instructions for Use.
†Refer to the Instructions for Use for indications, warnings, potential adverse events, and clinical experience associated with EVOQUE valve implantation in patients with pre-existing pacemakers.
Proven safety profile with favorable trends in all-cause mortality and HFH with EVOQUE TTVR
Favorable trends observed in all-cause mortality and heart failure hospitalizations at 1 year between EVOQUE TTVR and medical therapy alone.
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Kaplan-Meier All-Cause Mortality
Kaplan-Meier Heart Failure Hospitalization
30-day Safety profile
Meaningful health status improvement for patients with EVOQUE TTVR
At 1-year follow-up compared to baseline, patients treated with EVOQUE TTVR experienced meaningful and sustained TR improvements in quality-of-life, functional status, and exercise capacity.
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KCCQ-OS improvement
NYHA Class improvement
6MWD improvement
