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EVOQUE Tricuspid Valve Replacement System

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impact of tricuspid

The impact of tricuspid regurgitation

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Explore the
EVOQUE system

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See the
clinical evidence

A life-threatening condition like symptomatic severe TR deserves a revolutionary approach1

Medications may treat symptoms but not the TR itself, which can continue to progress. Reducing TR severity may improve patient quality of life.2,4

less than 225k

people in Canada are estimated to have clinically relevant TR5,6

19% of patients with mild or trivial TR progressed to moderate or severe TR in ~3

of patients with mild or trivial TR progressed to moderate or severe TR in ~3 years§,7

More than 20% estimated mortality in patients with severe TR within 1 year of diagnosis

estimated mortality in patients with severe TR within 1 year of diagnosis8, 9

The EVOQUE valve has the potential to eliminate tricuspid regurgitation

Tricuspid regurgitation
evoque heart
Tricuspid regurgitation vs EVOQUE valve

Move the arrow left or right to see the comparison between a heart with tricuspid regurgitation and one with the EVOQUE valve

Tricuspid regurgitation
evoque heart
Tricuspid regurgitation vs EVOQUE valve
patient icon

Reducing TR severity may improve patient quality of life2,4

§Based on a retrospective echocardiographic analysis of Israeli patients (n=1,552).

Meet the EVOQUE system

The EVOQUE system is the world's first transcatheter tricuspid valve replacement therapy

meet the evoque

Learn about the EVOQUE valve

EVOQUE Valve

*No clinical data are available that evaluates long-term impact of the Carpentier-Edwards ThermaFix tissue process in patients.

†Excluding Edwards SAPIEN 3 Ultra RESILIA valves.

A system designed with your symptomatic severe TR patients in mind

A transcatheter system designed for ease of use

‌
stopwatch icon

Procedural efficiency with an average device time of approximately one hour

Multiple valve sizes to treat a broad range of tricuspid anatomies

Multiple valve sizes

Transfemoral 28F outer diameter delivery system designed for maneuverability

Transfemoral 28F Device
Stabiliser, base, and plate
3 planes icon

Same delivery system for all valve sizes

See the clinical evidence

Superior clinical benefit and consistent TR resolution for patients with EVOQUE TTVR

see the clinical

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.

1 / 2

Patients experienced

2x

Greater likelihood of clinical benefit with EVOQUE TTVR vs medical therapy alone

Win Ratio

2.02

 (95% CI,  1.56 to 2.62; p<0.001)

Composite endpoint

Patients experienced

2x

Greater likelihood of clinical benefit with EVOQUE TTVR vs medical therapy alone

Win Ratio

2.02

 (95% CI,  1.56 to 2.62; p<0.001)

Win ratio analysis
Composite endpoint

Composite Endpoint

Win ratio analysis

Win Ratio Analysis

Patients experienced

2x

Greater likelihood of clinical benefit with EVOQUE TTVR vs medical therapy alone

Win Ratio

2.02

 (95% CI,  1.56 to 2.62; p<0.001)

Patients experienced

2x

Greater likelihood of clinical benefit with EVOQUE TTVR vs medical therapy alone

Win Ratio

2.02

 (95% CI,  1.56 to 2.62; p<0.001)

Consistent TR resolution in a broad patient population with EVOQUE TTVR

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Consistent TR Resolution

95.3%

≤mild TR with EVOQUE TTVR at 1 year 

Reproducible Procedure

<1 hour

median device time

TR Reduction

Treats diverse patient anatomies

Treats a diverse patient population

Treats a broad patient population

Treats a broad patient population
TR Reduction

TR Reduction

Treats a diverse patient population

Treats a diverse patient population

Treats a broad patient population

Treats a broad patient population

Consistent TR Resolution

95.3%

≤mild TR with EVOQUE TTVR at 1 year 

Reproducible Procedure

<1 hour

median device time

Treats diverse patient anatomies

Treats a broad patient population

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 estimate for all-cause mortality at 1 year

12.6%

with EVOQUE TTVR vs 15.2% with medical therapy alone

Kaplan-Meier All-Cause Mortality

Kaplan-Meier estimate for heart failure hospitalization at 1 year

20.9%

with EVOQUE TTVR vs 26.1% with medical therapy alone

Kaplan-Meier Heart Failure Hospitalization

30-day safety profile

3.1%

Cardiovascular mortality

0.4%

Stroke

10.4%

Severe bleeding

24.7%

New pacemaker implant in pacemaker-naïve patients

30-day Safety profile
Kaplan-Meier All-Cause Mortality

Kaplan-Meier All-Cause Mortality

Kaplan-Meier Heart Failure Hospitalization

Kaplan-Meier Heart Failure Hospitalization

30-day Safety profile

30-day Safety profile

Kaplan-Meier estimate for all-cause mortality at 1 year

12.6%

with EVOQUE TTVR vs 15.2% with medical therapy alone

Kaplan-Meier estimate for heart failure hospitalization at 1 year

20.9%

with EVOQUE TTVR vs 26.1% with medical therapy alone

30-day safety profile

3.1%

Cardiovascular mortality

0.4%

Stroke

10.4%

Severe bleeding

24.7%

New pacemaker implant in pacemaker-naïve patients

Dramatic 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

18.4-point

improvement in KCCQ-OS with EVOQUE TTVR at 1 year compared to baseline

KCCQ-OS improvement

NYHA Class improvement

91.0%

of EVOQUE TTVR patients in NYHA Class I/II at 1 year

NYHA Class improvement

6MWD improvement

23.2m

improvement in 6MWD with EVOQUE TTVR at 1 year compared to baseline

6MWD improvement
KCCQ-OS improvement

KCCQ-OS improvement

NYHA Class improvement

NYHA Class improvement

6MWD improvement

6MWD improvement

KCCQ-OS improvement

18.4-point

improvement in KCCQ-OS with EVOQUE TTVR at 1 year compared to baseline

NYHA Class improvement

91.0%

of EVOQUE TTVR patients in NYHA Class I/II at 1 year

6MWD improvement

23.2m

improvement in 6MWD with EVOQUE TTVR at 1 year compared to baseline

Helpful resources

EVOQUE Brochure thumbnail

EVOQUE system brochure

View brochure
TRISCEND II 6-Month Clinical summary thumbnail

TRISCEND II trial primary outcomes summary

View summary
TRISCEND II Logo

TRISCEND II Publication

View the clinical publication
TRISCEND II Trial quality

TRISCEND II trial quality of life outcomes summary

View summary

References

  1. Topilsky Y, Nkomo VT, Vatury O, et al. Clinical outcome of isolated tricuspid regurgitation. JACC Cardiovasc Imaging. 2014;7(12):1185-1194. 
  2. Fender EA, Zack CJ, Nishimura, RA. Isolated tricuspid regurgitation: Outcomes and therapeutic interventions. Heart. 2017;104:798-806.
  3. Otto C., et al. 2020 ACC/AHA Guideline for the Management of Patients with Valvular Heart Disease. Circulation. 143:5, Feb 2021 e27-227. 
  4. Kelly BJ, Ho Luxford JM, Butler CG, Huang C-C, Wilusz K, Ejiofor JI, et al. Severity of tricuspid regurgitation is associated with long-term mortality. The Journal of Thoracic and Cardiovascular Surgery 2018;155:1032–8.
  5. Topilsky et al. Burden of Tricuspid Regurgitation in Patients Diagnosed in the Community Setting. JACC Cardiovasc Imaging. 2019 Mar;12(3):433-442.
  6. Statistics Canada. Population estimates on July 1, by age and gender. 2024
  7. Mutlak D, Khalil J, Lessick J, Kehat I, Agmon Y, Aronson D. Risk factors for the development of functional tricuspid regurgitation and their population-attributable fractions. JACC: Cardiovascular Imaging 2020;13:1643–51.
  8. Chorin E, Rozenbaum Z, Topilsky Y, Konigstein M, Ziv-Baran T, Richert E, et al. Tricuspid regurgitation and long-term clinical outcomes. European Heart Journal - Cardiovascular Imaging 2019:157–65.
  9. Messika-Zeitoun D, Verta P, Gregson J, Pocock SJ, Boero I, Feldman TE, et al. Impact of tricuspid regurgitation on survival in patients with heart failure: a large electronic health record patient-level database analysis. European Journal of Heart Failure 2020; 22:1803-1813.