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TEER

TRICLIP™ TRANSCATHETER TRICUSPID VALVE REPAIR SYSTEM

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.

Choose Safety. Choose Repair.

TriClip Transcatheter Edge-to-Edge device is the only TEER device intentionally designed for the tricuspid valve, with stable navigation and precise delivery2,14 to safely maximize tricuspid regurgitation (TR) reduction and achieve sustained clinically
significant improvement in the quality of life of patients with TR.3,4

  • Significant TR reduction3,4
  • Exceptional safety profile4,5
  • Life changing improvements in health related quality of life3-5
  • Proven in randomized and real-world studies.3,4

A state-of-the-art treatment option for patients at intermediate or greater risk for surgery

TriClip TEER is a low-risk,5 non-surgical treatment option 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.

  • 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 day4
  • Patients with severe tricuspid regurgitation have significantly impaired quality of life12
    • Shortness of breath
    • Peripheral edema
    • Ascites
    • Fatigue
    • Declining exercise capacity
  • Current treatment options have limitations

    Medical therapy for TR has little impact on TR reduction5

    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

FEATURES

EXCEPTIONAL SAFETY4,5

MAXIMIZED EFFECTIVENESS4,5

LIFE-CHANGING IMPACT3-5

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

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 anatomy2,14
    • 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 valve plane

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

  • Designed for direct access to the tricuspid valve2,15

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

  • Confirm and optimize leaflet grasping

  • Implant and gripper line 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 anatomy2,14

    • 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 valve plane
  6. Designed for direct access to the tricuspid valve2,15
  7. Confirm and optimize leaflet grasping
  8. Implant and gripper line detachment

Test(s) performed by and data on file at Abbott.

  • Building on a legacy of unmatched TEER expertise13

    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 Features1

    • Elgiloy® implants with nitinol grippers
    • Polyester cover designed to promote tissue growth
    • Magnetic resonance conditional to 3 Tesla†

    †Static magnetic field of 1.5 T or 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.
     

  • 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 along the entire inserted leaflet length11
    • Four or six rows of short frictional elements designed to provide atraumatic leaflet engagement11
  • Broad range of sizes for tailored treatment

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

MAT-2401619 v1.0 | Item approved for U.S. use only.

References
  1. TriClip G4 System IFU.
  2. Test(s) performed by and data on file at Abbott. (RPT2118537)
  3. 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.
  4. 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.
  5. Sorajja P, Whisenant B, Hamid N, et al. Transcatheter repair for patients with tricuspid regurgitation. NEJM. March 4, 2023. doi: 10.1056/NEJMoa2300525.
  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.
  11. Test(s) performed by and data on file at Abbott. (RPT2133700, RPT2122822-R, RPT2124838-R)
  12. www.mayoclinic.org. Assessed
  13. Data on File at Abbott.
  14. Test(s) performed by and data on file at Abbott. (RPT2105461-R)
  15. Test(s) performed by and data on file at Abbott. (RPT2124196-R)
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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