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TEER

MITRACLIP™ Transcatheter Edge-to-Edge Repair

MitraClip™ is the first minimally invasive TEER* therapy that delivers a life-changing treatment option for select patients with primary or secondary mitral regurgitation who would otherwise go untreated.1,2 MitraClip is the standard of care in TMVr built on the only proven mitral valve therapy with over 20 years of experience, an extensive body of clinical evidence, and more than 200K patients treated worldwide.3

*TEER is also referred to TMVr (Transcatheter Mitral Valve Repair)

MitraClip™ procedure video

Built to Repair. Proven to Restore.

MitraClip delivers uncompromising performance in TEER and sets the standard in clinical outcomes. With each generation of MitraClip, Abbott remains at the forefront of therapeutic expertise, partnering with heart teams to help select patients with MR reclaim their lives.

A better quality of life is possible for your patients with MR


The MitraClip G4 System is indicated for patients with significant symptomatic primary (degenerative) mitral regurgitation (MR ≥ 2+), or with symptomatic, secondary (functional) mitral regurgitation (MR ≥ 2+).

The catalyst for a significant evolution in MR guidelines

MitraClip is the first TEER (TMVr) therapy recommended by AHA/ACC/HFSA and ESC/EACTS guidelines and ASPC recommendations for select primary and secondary* MR patients. The guidelines support aggressive monitoring and early action, with the goal of preventing complications due to LV volume overload.10-12


*Severely symptomatic SMR patients despite optimal GDMT.
 

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.5 If left untreated, MR initiates a cascade of events leading to death, with 1-year mortality up to 57%6

IDENTIFYING PATIENTS FOR MITRACLIP THERAPY


MitraClip Transesophageal Echo (TEE) Screening Guide
 

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MitraClip Procedural Positioning and Imaging Guide
 

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MitraClip Transthoracic Echo (TTE)
Screening Guide
 

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TAILORED. OPTIMIZED. PROVEN.

Tailored. Optimized. Proven.
MitraClip™ G4

MitraClip TEER system’s dedicated design for the mitral anatomy optimizes navigation for consistent clinical results. Its proven performance and tailored treatment options allow it to treat the broadest range of mitral anatomies.

  • Broad range of sizes for tailored treatment7,8,13

    MitraClip G4 offers 4 Clip sizes to help tailor repair based on patient mitral valve anatomy.

    • G4 NT is the original MitraClip NT/NTR Clip size
    • G4 XT is the equivalent of XTR, with Clip arms that are 3 mm longer than G4 NT and allow for easier grasping due to better reach**
       

    The G4 NTW and XTW clips have a 50% wider grasping area than the NT and XT clips respectively. They are designed to further reduce regurgitant volume reduce MR with the implantation of a single clip.**

  • Treat more patients with more options7-10,13

    MitraClip successfully treats a broad range of valve anatomies in real world use7-10,13

    Significant and durable MR reduction achieved in patients with complex anatomies7

    90.3% of complex subjects achieved MR <1+ at 1 year.7


    This was the best MitraClip case we have ever done … Gen 4 is a game-changer.

    – Experienced Interventional Cardiologist commenting on MitraClip G4*
     

    *The testimonial does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual’s experience and might not be representative of others.

    Ability to choose clip size based on each MV anatomy8,9

    CLIP SELECTION CONSIDERATIONS

    		FAVORS
    G4 NTW    		FAVORS
    G4 NT    		FAVORS
    G4 XTW    		FAVORS
    G4 XT
    Leaflet length < 9mm++  
    Leaflet length ≥ 9mm  ++
    Broad jet+ + 
    Smaller valve +  
    Larger valve+ ++

    MitraClip G4 clip selection recommendations were based on the initial clinical experience of an expert panel of physicians.8,9

    The EXPAND G4 real world study results further demonstrated clip selection preference and associated outcomes:8

    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

    MitraClip G4 CGA with new gripper levers

    Simultaneous
    grasping

    MitraClip G4 CGA with simultaneous grasping

    Independant
    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 control from delivery system specifically designed for the mitral valve**
     

  • Increased procedural efficiency1,7

    Greater proportion
    of patients treated
    with 1 clip7

    MitraClip implantation

    Only 1 clip in
    65% of cases7
     

    Shortest
    device time to date in TEER7
     

    35 min. median
    device time7



    “In our institute, we have now reduced device time to ~20 min."

    Experienced Echocardiographer commenting on MitraClip G4*
     

    *The testimonial does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual’s experience and might not be representative of others.

    Simplified procedural steps1

    • 40% reduction in system preparation steps
    • Simplified system deployment with minimal number of steps
       

CLINICAL DATA


See the latest clinical data for MitraClip
 

see clinical data

MAT-2010221 v6.0 | Item approved for OUS use only.

References

*The testimonial does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual’s experience and might not be representative of others.
**Tests performed by and data on file at Abbott.

  1. MitraClip G4 System Instructions for Use.
  2. 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.
  3. Data on file at Abbott.
  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. 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.
  6. 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.
  7. R S von Bardeleben, R, Mahoney, P, Morse, M. 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.
  8. Maisano F. Clip Selection Strategy with 4th Generation MitraClipTM: Evidence-Based Recommendations from the Global EXPAND G4 Study. Data presented at PCR London Valve 2022
  9. R S von Bardeleben, et. al. Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair J Am Coll Cardiol Intv. 2023 Jun, 16 (12) 1463–1473
  10. Vahanian A, Beyersdorf F, Praz F, et al., ESC/EACTS Scientific Document Group, 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS), European Heart Journal, Volume 43, Issue 7, 14 February 2022, Pages 561–632, https://doi.org/10.1093/eurheartj/ehab368
  11. Yeo KK, Tan JWC, Muller DW, et al. Asian Pacific Society of Cardiology Consensus Recommendations on the Use of MitraClip for Mitral Regurgitation. Eur Cardiol. 2021;16:e25. Published 2021 Jun 1. doi:10.15420/ecr.2021.01
  12. McDonagh TA, Metra M, Adamo M,  et al., ESC Scientific Document Group, 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC, European Heart Journal, Volume 42, Issue 36, 21 September 2021, Pages 3599–3726, https://doi.org/10.1093/eurheartj/ehab368
  13. JH Rogers et al, Expanding the Spectrum of TEER Suitability: Evidence from the EXPAND G4 Post Approval Study. JACC Cardiovasc Interv, 2023, 16(12): 1474-1485.
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