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TEER

TRICLIP™ TRANSCATHETER TRICUSPID VALVE REPAIR CLINICAL DATA

TriClip™ Transcatheter Edge-to-Edge Repair (TEER) offers a minimally invasive treatment option to improve quality of life (QoL) and functional status in patients with symptomatic severe tricuspid regurgitation, despite optimal medical therapy, who are at intermediate or greater risk for surgery.

INSPIRED BY PATIENTS. MADE POSSIBLE BY YOU.

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).2-6

EXCEPTIONAL SAFETY.*2,10
LIFE-CHANGING IMPACT.2,9,10

The TRILUMINATE™ Pivotal Trial demonstrated that TriClip TEER therapy was superior to medical therapy alone in improving quality of life and reducing tricuspid regurgitation.

Remarkable and Sustained TR Reduction2

TR Grade (Core Lab)

 

  • Exceptional safety at 30 days2,10

    98.3%

    FREEDOM
    FROM MAEs

    0.6%

    NEW PACEMAKER
    IMPLANTATION

    0%

    DEVICE THROMBUS

    99.4%

    SURVIVAL

    0%

    NONELECTIVE CV
    SURGERY FROM
    DEVICE-RELATED AE

    0%

    DEVICE EMBOLIZATION

  • Significant Improvement in Health-Related Quality of Life2
  • Baseline Population Characteristics2

    71%

    OF PATIENTS HAD MASSIVE
    OR TORRENTIAL TR

    4.4±0.7cm

    TRICUSPID VALVE
    ANNULUS DIAMETER

    >35%

    OF PATIENTS WITH PRIOR
    MITRAL OR AORTIC VALVULAR INTERVENTION

    15%

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

    *At 30 days

PROVEN ACROSS A BROAD
RANGE OF ANATOMIES7,8

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 Reduction7

TR Grade (Core Lab)

 

  • Successfully Treated a Broad Range of Anatomies8
  • Proven Durability Backed by Clinical Data7

    NYHA Functional Class

    KCCQ - OS

  • TriClip TEER demonstrated Procedural Success and an Exceptional Safety Profile5

    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

     

PROVEN SAFETY AND EFFECTIVENESS

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

93%

SURVIVAL
AT 1 YR3

100%

IMPLANT
SUCCESS4

91%

ACUTE PROCEDURAL
SUCCESS RATE4

0%

STROKE4

0%

CONVERSION TO
SURGERY4

  • Significant and Durable TR Reduction11

    Durable reduction in tricuspid regurgitation (TR)

  • Significant improvement in function and quality of life11

    Durable improvements in NYHA


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

  • Significant reduction in hospitalizations4

    Reduced hospitalization rate
     

MAT-2401620 v1.0 | Item approved for U.S. use only.

References
  1. Data on file at Abbott.
  2. Sorajja P, Whisenant B, Hamid N, et al. Transcatheter repair for patients with tricuspid regurgitation. NEJM. March 4, 2023. doi: 10.1056/NEJMoa2300525.
  3. 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.
  4. 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.
  5. Lurz P, Besler C, Schmitz T, et al. Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice. JACC. 2023;82(4):281-291.
  6. 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.
  7. Lurz P, Schmitz T, Bekeredjian R, et al. Real-world Outcomes for Tricuspid Edge-to-Edge Repair: Initial 1 Year Outcomes from the bRIGHT trial. Presented at PCR London Valves; November 27-29, 2022; London, England.
  8. Lurz P et al. Real-world Outcomes for Tricuspid Edge-to-Edge Repair: Initial 30-Day Results with TriClip™ G4 from the bRIGHT Study Presented at PCR London Valves 2022.
  9. Estevez-Loureiro R. Real-world Outcomes for Tricuspid Edge-to-Edge Repair: Initial 2-year Outcomes from the bRIGHT Trial. Presented at PCR London Valves on November 19-21, 2023; London, UK.
  10. Adams D, Sorajja P, et al. TRILUMINATE Pivotal: Outcomes of All Randomized and Single-arm Subjects with Transcatheter Tricuspid Valve Edge-to-Edge Repair for Tricuspid Regurgitation. Presented at TCT on October 24,2023; San Francisco, CA; USA.
  11. Nickenig G. Percutaneous edge-to-edge repair for tricuspid regurgitation: 3-year outcomes from the TRILUMINATE trial. Presented at PCR London Valves on November 19-21, 2023;
Important Safety Information

Rx Only

TRICLIP™ G4 SYSTEM

INDICATION FOR USE

The TriClip™ G4 System is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.

CONTRAINDICATIONS

The TriClip G4 System is contraindicated in patients with the following conditions: Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation; Untreatable hypersensitivity to Implant components (nickel-titanium alloy, cobalt-chromium alloy); Active endocarditis or other active infection of the tricuspid valve.

POTENTIAL ADVERSE EVENTS

The following events have been identified as possible complications of the TriClip G4 Procedure. Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials and drug reactions to anticoagulation, or antiplatelet drugs; Additional treatment/surgery from device-related complications; Bleeding; Blood disorders (including coagulopathy, hemolysis, and heparin induced thrombocytopenia (HIT)); Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, unstable angina, and stable angina); Cardiac perforation; Cardiac tamponade; Chest pain; Death; Dyspnea; Edema; Embolization (device or components of the device); Endocarditis; Fever or hyperthermia; Fluoroscopy and transesophageal echocardiogram (TEE) related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding; Hypotension/hypertension; Infection including: Septicemia; Nausea or vomiting; Pain; Pericardial effusion; Stroke/cerebrovascular accident (CVA) and transient ischemic attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction or failure or atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Thrombosis; Tricuspid valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement/rupture, Single leaflet device attachment (SLDA), Dislodgement of previously implanted devices, Tissue damage, Tricuspid valve stenosis, Worsening, persistent or residual regurgitation; Vascular access complications which may require additional intervention, including: Wound dehiscence, Bleeding of the access site, Arteriovenous fistula pseudoaneurysm, aneurysm, dissection, perforation (rupture), vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury; Venous thrombosis (including deep vein thrombosis) and thromboembolism (including pulmonary embolism).

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