TEER

TRICLIP™ TRANSCATHETER TRICUSPID VALVE REPAIR CLINICAL DATA

TriClip™ Transcatheter Edge-to-Edge repair offers a minimally invasive treatment option for patients with severe symptomatic tricuspid regurgitation (TR).

TEER

TRICLIP™ TRANSCATHETER TRICUSPID
VALVE REPAIR
CLINICAL DATA

TriClip™ Transcatheter Edge-to-Edge repair offers a minimally invasive treatment option for patients with severe symptomatic tricuspid regurgitation (TR).

THE STANDARD OF CARING FOR TR

TriClip TEER has shown meaningful outcomes in both real-world and randomized clinical data. The bRIGHT study and TRILUMINATE™ Pivotal Trial demonstrated the safety and effectiveness of TriClip TEER in the treatment of severe tricuspid regurgitation (TR).1,4

TRILUMINATE™ PIVOTAL TRIAL

Exceptional safety.1,2
Life-changing impact.1,4

The TRILUMINATE™ Pivotal Trial demonstrated that TriClip TEER Therapy was superior to medical therapy alone reducing risk of heart failure hospitalization and improving quality of life.

Remarkable and sustained TR reduction3

TR grade (Core Lab)

 

  • Exceptional safety at 30 days1,3

    98.9%

    FREEDOM
    FROM MAEs

    0.9%

    NEW PACEMAKER
    IMPLANTATION

    0%

    DEVICE THROMBUS

    99.6%

    SURVIVAL

    0%

    NONELECTIVE CV
    SURGERY FROM
    DEVICE-RELATED AE

    0%

    DEVICE EMBOLIZATION

  • Significant improvement in health-related quality of life3
  • Baseline population characteristics5

    73%

    OF PATIENTS HAD MASSIVE
    OR TORRENTIAL TR

    4.3±0.8cm

    TRICUSPID VALVE
    ANNULUS DIAMETER

    38%

    OF PATIENTS WITH PRIOR
    MITRAL OR AORTIC VALVULAR INTERVENTION

    17%

    OF PATIENTS HAD A CRT, CRT-D, ICD,
    OR PERMANENT PACEMAKER

bRIGHT STUDY

Proven across a broad
range of anatomies4,6

The bRIGHT Study demonstrated that TriClip™ TEER significantly reduced TR across a broad range of anatomies - in a safe and effective procedure - resulting in durable and meaningful clinical outcomes.

Designed to maximize TR reduction2,4,7

TR grade (Core Lab)

 

  • Successfully treated a broad range of anatomies6
  • Proven durability backed by clinical data

    NYHA Functional Class7

    KCCQ - OS Score2

  • TriClip TEER demonstrated procedural success and an exceptional safety profile8

    HIGH PROCEDURAL
    SUCCESS

    99.0%

    Implant
    sucess rate

    SHORT
    DEVICE TIME
     

    76±39

    Minutes

    HIGH SAFETY
    PROFILE
     

    97.5%

    Freedom
    from MAEs
    at 30 days



    99.0% survival at 30 days

    0.2% TV reintervention

    0.0% embolization

     

TRILUMINATE™ TRIAL

Proven safety and effectiveness

The TRILUMINATE™ Trial demonstrated that TriClip TEER safely and effectively reduces TR and HF hospitalizations. 

93%

SURVIVAL
AT 1 YR10

100%

IMPLANT
SUCCESS10

91%

ACUTE PROCEDURAL
SUCCESS RATE10

0%

STROKE10
AT 30 DAYS

0%

CONVERSION TO
SURGERY10
AT 30 DAYS

  • Significant and durable TR reduction11

    Durable reduction in tricuspid regurgitation (TR)

  • Significant improvement in functional status and quality of life11

    Durable improvements in NYHA


    ≥10-point KCCQ-OS score improvement was observed in 50% of subjects at three years.11

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