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TEER

MITRACLIP™ Transcatheter Edge-to-Edge Repair (TEER)

Uncompromising performance that sets the standard in mitral valve repair. With over 20 years of experience, extensive clinical evidence, and more than 250K patients treated worldwide.1


Control Meets Efficiency

G5 is the next evolution of the MitraClip TEER system offering easy handling, precise positioning, and intuitive deployment that enhances both control and efficiency, allowing you to focus on what matters most — your patients

A better quality of life is possible for your patients with Mitral Regurgitation (MR)


MitraClip™ TEER is designed to deliver a life-changing result for:2-3

  • Select patients with significant primary MR patients who are at prohibitive surgical risk
  • Select patients with significant secondary MR patients who are symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT)
Scott, MitraClip TEER Patient

“Scott is a lifelong athlete who found himself on the sidelines with significant mitral regurgitation. Learn about his experience receiving MitraClip therapy and his journey back to an active lifestyle.”

This testimonial relates an account of an individual’s response to the treatment. This patient’s account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

The foundation for TEER guideline recommendations

MitraClip TEER therapy presents the largest body of clinical evidence that serves as the basis for TEER recommendations for valvular heart disease and heart failure management across the world.

TEER therapy is recommended by both the 2022 AHA/ACC/HFSA Guideline4 and the 2020 ACC/AHA Guideline5 for select primary and secondary MR patients.

Severe MR is vastly undertreated

  • Surgical intervention not offered or denied
    Severe MR is vastly undertreated with no surgical intervention


    49% of patients with symptomatic severe MR were not operated due to age, co-morbidities, or impaired LV.6 If left untreated, MR initiates a cascade of events leading to death, with 1-year mortality up to 57%7

IDENTIFYING PATIENTS FOR MITRACLIP THERAPY


Transcatheter Mitral Valve Repair Patient Selection
Criteria Guide
 

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MitraClip G5 TEER System

MitraClip G5
1
2
3
4
5
  1. Guide Attach
  2. DS Attach
  3. DC Fastener
  4. Lock Line Release Latch
  5. Lock Line Release Slider

Delivery Catheter (DC) Handle

  • Handle has integrated gripper levers and reduced flush volume.

    • Arm Positioner

  • Hard stop within arm positioner in open direction.

    • Release Pin

  • Finger hold to pull and initiate clip deployment.

    • Lock Line Release Latch

  • Releases one end of lock line at time of deployment.

    • Lock Knob

  • Discrete lock and unlock positions and no blue line.

    • Delivery System (DS) Attach

  • Spring-loaded attachment slides into stabilizer rail. Replaces black screw.

    • Stabilizer

  • Stabilizer rail and handles to support the movement of the delivery system.

    • Guide Attach

  • Spring-loaded attachment with pins for insertion into stabilizer dock. Replaces black screws and the need to tighten screw to secure position.

    • Guide Attachment Braking System

  • Allows for adjustable guide positioning and holds guide catheter position. Replaces black screw.

    • Built-in DC Fastener

  • Rotation of fastener counterclockwise secures delivery catheter. Replaces black screw.

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

    Easy Handling. Precise Positioning. Intuitive Deployment.

    The MitraClip G5 system is designed to support procedural control and efficiency in mitral valve repair. With thoughtfully integrated enhancements, the system facilitates connection, movement, and disconnection with minimal complexity. Key updates include refined attachment mechanisms and securement features, contributing to a more streamlined procedural experience.

    Learn more about the additional benefits of MitraClip TEER.

    • Broad range of sizes for tailored treatment8-11

      MitraClip TEER offers 4 clip sizes to help tailor repair based on patient mitral valve anatomy.

      The NTW and XTW clips have a 50% wider grasping area than the NT and XT clips respectively. They are designed to tailor the treatment and further reduce MR with 4 clip options. **

    • Treat more patients with more options8-11

      MitraClip successfully treats a broad range of valve anatomies in real world use8-11

      Significant and durable MR reduction achieved in patients with complex anatomies11

      90.3% of complex subjects achieved MR ≤1+ at 1 year.11

      Ability to choose clip size based on each MV anatomy8,10

      CLIP SELECTION CONSIDERATIONSFAVORS
      NTW      		FAVORS
      NT      		FAVORS
      XTW      		FAVORS
      XT
      Leaflet length < 9mm++  
      Leaflet length ≥ 9mm  ++
      Broad jet+ + 
      Smaller valve +  
      Larger valve+ ++

      MitraClip TEER clip selection recommendations were based on the initial clinical experience of an expert panel of physicians using the 4 clip sizes of MitraClip G4.8,10

      The EXPAND G4 real world study further demonstrated clip selection preference and associated outcomes10:

      FOR PATIENTS WITH PMR

      XTW was used most often and achieved favorable MR reduction, particularly in patients with longer leaflets, large prolapse or wider jets, calcified leaflets or annulus and Barlow’s or bileaflet prolapse

      FOR PATIENTS WITH SMR

      NTW and XTW were used evenly across anatomies and achieved favorable MR reduction

      FOR ALL MR ETIOLOGIES

      NT and XT were used more frequently in multiple-clip cases and improved MR reduction

    • More options to confirm and optimize leaflet grasping with Controlled Gripper Actuation (CGA)1,**

      Controlled Gripper Actuation (CGA) provides the option to grasp leaflets simultaneously or independently, enabling the ability to confirm and optimize leaflet grasp.

      New gripper
      levers

      Simultaneous
      grasping

      MitraClip G4 CGA with simultaneous grasping

      Independent
      grasping

      MitraClip G4 CGA with independent grasping
    • Predictable procedure experience**

      The innovative Clip Delivery System is a highly maneuverable delivery catheter that is used to implant the MitraClip via a Steerable Guide Catheter.

      Precision and stability from a delivery system specifically designed for the mitral valve**
       

    Webinars

    Watch our webinars to learn more about how MitraClip can benefit physicians and help patients live longer, fuller lives.

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    MAT-2010220 v10.0 | Item approved for U.S. use only.

    References

    **Tests performed by and data on file at Abbott.

    1. Data on file at Abbott.
    2. MitraClip G4 System Instructions for Use.
    3. Lim DS, Reynolds MR, Feldman T, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after the transcatheter mitral valve repair. J Am Coll Cardiol. 2014;64(2):182-192.
    4. Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association. Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. Apr 01, 2022. Epublished DOI: 10.1016/j.jacc.2021.12.012
    5. Otto C, et al. 2020 ACC/AHA Guideline for the Management of Patients with Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Corrected version. Circ. 2021;143(5):e72-e227.
    6. Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28(11):1358-1365.
    7. Cioffi G, Tarantini L, De Feo S, et al. Functional mitral regurgitation predicts 1-year mortality in elderly patients with systolic chronic heart failure. Eur J Heart Fail. 2005;7(7):1112-1117.
    8. Von Bardeleben RS, Rogers J, Mahoney P, et al. Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair: 30-Day Results From EXPAND G4. J Am Coll Cardiol Intv. 2023 Jun, 16 (12) 1463-1473.
    9. Von Bardeleben RS, Mahoney P, Morse MA, et al. 1-Year Outcomes with Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair from the EXPAND G4 Study. J Am Coll Cardiol Intv. 2023 Nov. 16(21):2600-2610.
    10. Maisano F, Clip Selection Strategy with 4th Generation MitraClip™: Evidence-Based Recommendations from the Global EXPAND G4 Study. Data presented at PCR London Valve 2022.
    11. Rogers JH, et al. Expanding the Spectrum of TEER Suitability: Evidence from the EXPAND G4 Post Approval Study. JACC Cardiovasc Interv, 2023, 16(12): 1474-1485.
    Important Safety Information

    Rx Only

    MITRACLIP™ CLIP DELIVERY SYSTEM

    INDICATIONS FOR USE

    The MitraClip™ G5 System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

    The MitraClip™ G5 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

    CONTRAINDICATIONS

    The MitraClip™ G5 System is contraindicated for use 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 mitral valve

    POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

    The following events have been identified as possible complications of the MitraClip™ G5 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; Atrial septal defect; 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; Mitral 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, Mitral valve stenosis, Worsening, persistent or residual regurgitation; 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; 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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