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TEER

TRICLIP™ TRICUSPID VALVE REPAIR CLINICAL DATA

Built upon a proven clip-based platform, TriClip™ Transcatheter Edge-to-Edge Repair (TEER) offers a minimally invasive treatment option for patients with symptomatic, severe tricuspid regurgitation (TR) who are at high risk for surgery.

TEER

TRICLIP™ TRICUSPID
VALVE REPAIR
CLINICAL DATA

Built upon a proven clip-based platform, TriClip™ Transcatheter Edge-to-Edge Repair (TEER) offers a minimally invasive treatment option for patients with symptomatic, severe tricuspid regurgitation (TR) who are at high risk for surgery.

MEANINGFUL OUTCOMES BACKED BY ROBUST EVIDENCE

A large body of evidence from the TRILUMINATE  clinical study and the bRIGHT real-world study demonstrate meaningful outcomes with TriClip™ Transcatheter Edge-to-Edge Repair in patients with symptomatic, severe tricuspid regurgitation (TR).1-4 

OUTCOMES IN REAL-WORLD STUDIES3
THE FUTURE IS bRIGHT

bRIGHT real-world study initial 30-day results

Proven in the largest and first Tricuspid TEER real-world study to date, the bRIGHT study demonstrates that TriClip™ TEER significantly reduces TR with tailored therapy across a broad range of patient anatomies, resulting in meaningful clinical outcomes in a safe and effective procedure.

98%

IMPLANT
SUCCESS

90%

ACUTE PROCEDURAL
SUCCESS

0.5%

ALL-CAUSE
MORTALITY

0.5%

STROKE

0.5%

CONVERSION TO
SURGERY

  • Significant TR reduction at 30 days3
    Significant tricuspid regurgitation (TR) reduction for TriClip TEER System


     

  • Strong real-world clinical outcomes at 30 days3
    76 percent of patients with NYHA I/II at 30 days for TriClip TEER System clinical study


    19 Points significant improvement in KCCQ-OS health-related quality of life

  • TriClip TEER continues to demonstrate3

    HIGH PROCEDURAL
    SUCCESS

    98%

    Implant
    sucess rate

    SHORT
    DEVICE TIME
     

    78min
    ±42

     

    HIGH SAFETY
    PROFILE
     

    99%

    Freedom
    from MAEs



    99.5% survival

    1.5% reintervention

    0% embolization

     

TRILUMINATE™ CLINICAL TRIAL

Proven safety and effectiveness

93%

SURVIVAL
AT 1 YR2

100%

IMPLANT
SUCCESS4

91%

ACUTE PROCEDURAL
SUCCESS RATE4

0%

PROCEDURAL
STROKE4

0%

CONVERSION TO
SURGERY4

  • Significant and Durable TR Reduction2

    Durable reduction in tricuspid regurgitation (TR)

    Durable reduction in tricuspid regurgitation (TR) for TriClip TEER System clinical study
  • Significant improvement in function and quality of life2

    Durable improvements in NYHA

    Durable improvements in NYHA for TriClip TEER System clinical study


    20 Points significant improvement in KCCQ-OS health-related quality of life

  • TriClip TEER demonstrates high safety profile2

    High survival in a
    fragile patient population

    93%

    Survival
    at 1 year

     

    Low rates of
    major adverse events

    93%

    Freedom from MAEs
    at 1 year

  • Significant reduction in hospitalizations2

    Reduced hospitalization rate
     

    Reduced hospitalization rate for TriClip TEER System clinical study

MAT-2006556 v5.0 | Item approved for Global OUS use only.

References
  1. von Bardeleben RS, Lurz P, Sitges M, et al. Percutaneous edge-to-edge repair for tricuspid regurgitation: 2-year outcomes from the TRILUMINATE trial. Presented at: EuroPCR 2021.
  2. Lurz P, von Bardeleben RS, Weber M, et al. Transcatheter edge-to-edge repair for treatment of tricuspid regurgitation. J Am Coll Cardiol. 2021;77(3):229-239.
  3. Lurz P, Schueler R, Goebel B, et al. Real-world outcomes for tricuspid edge-to-edge repair: initial 30-day results from the TriClip bRIGHT Study. Presented at: PCR London Valves 2021.
  4. Nickenig G., Weber M., Lurz P., et al. Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. Lancet. 2019; 394 (10213): 2002-2011.Mandatory 
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