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TEER

TRICLIP™ TRICUSPID VALVE REPAIR

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

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. 

INTENTIONALLY DESIGNED FOR THE  TRICUSPID VALVE1

TriClip™ Transcatheter Edge-to-Edge Repair (TEER) offers unmatched stability, precision, and control2,* required for the unique challenges of the tricuspid anatomy to achieve sustained, clinically significant improvements in the lives of patients with tricuspid regurgitation (TR).3,4

  • Significant TR reduction3-5
  • Strong safety profile3-5
  • Life changing improvements in health related quality of life3-5
  • Proven in the largest body of Tricuspid TEER evidence to date3-5

* Based on Abbott simulated horizontal tensile testing.
 

A state-of-the-art treatment option for patients at high risk for surgery

TriClip TEER is a low-risk, minimally invasive, non-surgical treatment option for symptomatic patients with severe tricuspid regurgitation (TR) who are at high-risk for surgery and are not seeing improvement from medical therapy alone.

  • Transcatheter beating heart procedure - no cardiopulmonary bypass
  • Allows for real-time positioning and repositioning to optimize TR reduction
  • Femoral venous access
  • Can be used in a standard cath lab or hybrid room
  • No pre-procedural CT required
  • Fast recovery times; many patients go home the next day
TriClip
  • Patients with severe tricuspid regurgitation have significantly impaired quality of life
    • Shortness of breath
    • Peripheral edema
    • Ascites
    • Fatigue
    • Declining exercise capacity
       
  • Current treatment options have limitations

    For many patients with functional tricuspid regurgitation (FTR), medical management is not enough.

    Medical management for TR has little impact on survival6

    Medical management for TR has little impact on survival

    66%

    of patients with severe FTR die within 5 years of medical management6


    Most patients receive medical management until right heart failure or end-organ dysfunction appears.7

  • Surgery is high risk and often denied8-9

    Surgery for TR is seldom performed. Factors prohibiting surgery include:

    • High operative risk (6-16% in-hospital mortality)
    • Multiple comorbidities
    • Advanced age
    • Lack of effectiveness


    Long-term survival estimates for all patients undergoing surgical tricuspid valve replacement or repair10

    Long-term survival estimates for all patients undergoing surgical tricuspid valve replacement or repair

The Tricuspid Valve Has Finally Met Its Match

TriClip™ G4 TEER system.
Unmatched Stability, Precision, Control.2*

The TriClip™ G4 Transcatheter Edge-to-Edge Repair System empowers you with stable navigation and precise delivery
for complex conditions.

* Based on Abbott simulated horizontal tensile testing.

F/E Knob

S/L Knob

Steerable Guide Catheter

+/- Knob

Distal Curve

TriclipTM G4 Delivery System

Controlled Gripper Actuation

Actuator Knob

  • Flexes and extends delivery catheter to steer down to the valve plane

  • Enables movement in septal or lateral direction

  • Designed for the tricuspid anatomy
    • Provides adequate height over the valve
    • Maintains coaxial position during steering and positioning
    • Allows sweeping away from the septum to optimize delivery catheter while maintaining perpendicularity to the plane of the valve

  • Straightens or curves the guide to add or subtract height above the valve

  • Designed for direct access to the tricuspid valve

    • Provides stability and precision during steering and positioning
    • Multiaxis steering to enable navigation across all lines of coaptation

  • Confirm and optimize leaflet grasping

  • Simultaneous implant and gripper detachment

EPIC™ SUPRA AORTIC STENTED TISSUE VALVE FEATURES
1
2
3
4
5
6
7
8
    • Provides stability and precision during steering and positioning
    • Multiaxis steering to enable navigation across all lines of coaptation
  2. Flexes and extends delivery catheter to steer down to the valve plane
  3. Enables movement in septal or lateral direction
  4. Straightens and curves guide for height adjustment above the valve

  5. Designed for the tricuspid anatomy

    • Provides adequate height over the valve
    • Maintains coaxial position during steering and positioning
    • Allows sweeping away from the septum to optimize delivery catheter while maintaining perpendicularity to the plane of the valve
  6. Designed for direct access to the tricuspid valve
  7. Confirm and optimize leaflet grasping
  8. Simultaneous implant and gripper detachment
  • Building on a legacy of unmatched TEER expertise1

    TriClip™ implants use the same proven leaflet technology as our MitraClip™ Transcatheter Edge-to-Edge Repair (TEER). TriClip TEER is the clip-based technology physicians know and trust, with a delivery system uniquely designed for the tricuspid valve.

    TriClip™ Implant Features

    • Cobalt-chromium and Nitinol construction
    • Polyester cover designed to promote tissue growth
    • Magnetic resonance conditional to 3 Tesla†


    †Static magnetic field up to 3 T; maximum spatial gradient in static field of 4000 gauss/cm or less; maximum whole-body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning.
     

  • Broad range of sizes for tailored treatment

    Four implant sizes are available for patient-specific therapy with the TriClip G4 TEER System.1

    TriClip G4 TEER System implant sizes at 120 degrees
    TriClip G4 TEER System implant sizes at 120 degrees
  • Optimized leaflet capture

    Optimized leaflet capture for consistent TR reduction with the TriClip G4 TEER system

    • Wide grasp opening allows full leaflet insertion1
    • Designed to distribute retention forces across the leaflets1
    • Controlled gripper actuation enables independent leaflet grasping and confirmation, when needed1
    Optimized leaflet capture for consistent TR reduction with the TriClip G4 TEER System


MAT-2006554 v6.0 | Item approved for OUS use only.

References
  1. Data on file at Abbott. 
  2. Testing performed by and data on file at Abbott.
  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, 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.  
  5. 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.
  6.  Benfari G, Antoine C, Mille WL, et al. Excess mortality associated with functional tricuspid regurgitation complicating heart failure with reduced ejection fraction. Circulation. 2019;140(3):196-206.
  7. Asmarats L, Puri R, Latib A, et al. Transcatheter tricuspid valve interventions: landscape, challenges, and future directions. J Am Coll Cardiol. 2018;71(25):2935-2956.
  8. Enriquez-Sarano M, Messika-Zeitoun D, Topilsky Y, et al. Tricuspid regurgitation is a public health crisis [published online ahead of print November 9, 2019]. Prog Cardiovasc Dis. 2019;62(6):447-451. Doi:10.1016/j.pcad.2019.10.009.
  9. Wong WK, Chen SW, Chou AH, et al. Late outcomes of valve repair versus replacement in isolated and concomitant tricuspid valve surgery: a nationwide cohort study. J Am Heart Assoc. 2020;9(8):e015637. doi:10.1161/JAHA.119.015637.
  10. Moraca RJ, Moon MR, Lawton JS, Guthrie TJ, Aubuchon KA, Moazami N, Pasque MK, Damiano RJ Jr. Outcomes of tricuspid valve repair and replacement: a propensity analysis. Ann Thorac Surg. 2009 Jan;87(1):83-8; discussion 88-9.
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