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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 18 years of experience, an extensive body of clinical evidence, and more than 150K 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


MitraClip™ transcatheter edge-to-edge repair (TEER) is a minimally invasive treatment option for select patients with:

  • Significant Primary MR patients who are at a prohibitive surgical risk
  • Significant secondary MR patients who remain symptomatic despite maximally tolerated GDMT

“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 catalyst for a significant evolution in MR guidelines

Transcatheter edge-to-edge repair (TEER) therapy is now recommended by both the 2022 AHA/ACC/HFSA Guideline4 and the 2020 ACC/AHA Guideline5 for select primary and secondary* MR patients. Determining the severity of MR is an important factor in the management of the condition. The guidelines4,5 support aggressive monitoring and early action, with the goal of preventing complications due to LV volume overload.4

MitraClip is the only US-approved TEER, serving as the foundation for TEER recommendations for both primary MR and secondary MR.4
 


*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


Transcatheter Mitral Valve Repair Patient Screening
Fact Sheet (For Primary MR)
 

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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 treatment8,9

    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**
       
    MitraClip G4 offers 4 Clip sizes based on patient mitral valve anatomy

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

    MitraClip G4 offers 4 Clip sizes based on patient mitral valve anatomy
  • Treat more patients with more options9-11

    MitraClip successfully treats a broad range of valve anatomies in real world use9-11

    Nearly 1 in 5 patients treated have valve anatomies considered complex9

    Valve anatomies include: presence of severely degenerative leaflets, wide flail gaps or widths, calcified landing zone, wide jet, primary jet outside of A2/P2, and more.9


    "Long arm clip use was associated with improved MR reduction for severe baseline MR, smaller annular dimensions, larger prolapse gaps and complex mitral valve anatomy in primary MR."

    – Cardiac Surgeon with over 10 years of experience with MitraClip*
     

    *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 Anatomy9,10

    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.9,10

    The EXPAND G4 real world study results further demonstrated clip selection preference and associated outcomes11:

    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 most often, evenly across anatomies and achieved favorable MR reduction

    FOR ALL MR ETIOLOGIES

    XT 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)1,3

    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

    INDEPENDENT
    GRASPING

    MitraClip G4 CGA with independent grasping
    MitraClip G4 CGA grippers for leaflet insertion
  • Predictable procedure experience8

    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 delivery system specifically designed for the mitral valve**
     

    Clip Delivery System for Mitraclip via Steerable Guide Catheter
  • Increased procedural efficiency1,10

    GREATER PROPORTION
    OF PATIENTS TREATED
    WITH 1 CLIP10

    MitraClip implantation

    1 CLIP IMPLANTED IN
    65% OF CASES10
     

    24% SHORTER
    DEVICE TIME10
     

    34 MIN. MEDIAN
    DEVICE TIME10



    “IN OUR INSTITUTE, WE HAVE NOW REDUCED DEVICE TIME TO ~20 MIN.”

    Echocardiographer with 6 years of MitraClip experience, commenting on MitraClip G4*




     

    Simplified procedural steps1

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

LEARN MORE ABOUT MITRACLIP G4 FEATURES BY VISITING MITRACLIP.COM

Learn more

MitraClip informational webinar

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 v5.0 | Item approved for U.S. use only.

References

**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. Otto C, Nishimura RA, Bonow RO, 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. J Am Coll Cardiol. 2021;77(4):e25-e197.
  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. Rottbauer WD. Contemporary Clinical Outcomes with MitraClip™ (NTR/XTR) System: Core-lab Echo Results from +1000 Patient the Global EXPAND Study. Data presented at PCR 2020.
  9. Maisano F. Clip Selection Strategy and Outcomes with MitraClip™ (NTR/XTR): Evidence-Based Recommendations from the Global EXPAND Study. Data presented at PCR 2020.
  10. Von Bardeleben R.S. Contemporary Clinical and Echocardiographic Outcomes of 1000+ Patients Treated with MitraClip™ G4: Results from the EPXAND G4 Post Approval Study. Data presented at TCT 2022.
  11. 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.
Important Safety Information

MITRACLIP DELIVERY SYSTEMS
INDICATION FOR USE
 

  • The MitraClip™ G4 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™ G4 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 G4 System is contraindicated in patients with the following conditions: Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regime; Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip G4 procedure: Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or vessel repair including: wound dehiscence, catheter site reactions, Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Emboli (air thrombotic material, implant, device component); Peripheral Nerve Injury; Lymphatic complications; Pericardial complications which may require additional intervention, including: Pericardial effuse on, Cardiac tamponade, Pericarditis; Cardiac complications which may require additional interventions or emergency cardiac surgery, including: Cardiac perforation, Atrial septal defect; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Thrombosis, Dislodgement of previously implanted devices, Tissue damage, Mitral valve stenosis, Persistent or residual mitral regurgitation, Endocarditis; Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Hypotension / hypertension; Infection including: Urinary Tract Infection (UTI), Pneumonia, Septicemia; Nausea / vomiting; Chest pain; Dyspnea; Edema; Fever or hyperthermia; Pain; Death; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation; Esophageal perforation, Gastrointestinal bleeding

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