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TEER

MitraClip Trancatheter Edge-to-Edge Repair Clinical Data

Standard-Setting clinical outcomes that never stand still, MitraClip is the only TEER therapy with positive durable outcomes to 5 Years.1-5 With unparalleled clinical outcomes, MitraClip has the highest reported MR reduction6, significant improvements in functional status and quality of life6, and is the only TMV therapy that improved survival and HF hospitalization in Secondary MR.7

A SAFE TREATMENT FOR MITRAL REGURGITATION, A HOPE FOR SELECT PATIENTS

Treating mitral regurgitation (MR) with MitraClip™ therapy can mean an improved quality of life and relief from the symptoms of heart failure. Clinical studies show that intervention with MitraClip transcatheter mitral valve repair (TMVr)—also referred to as TEER (transcatheter edge-to-edge repair)—can safely reduce MR in select patients despite their age or high rate of accompanying serious comorbidities, such as heart failure.8

1.5%

30-DAY
MORTALITY RATE

Evaluating contemporary real-world clinical outcomes in patients treated with MitraClip G4 system.6

96.6%

FREEDOM FROM
DEVICE-RELATED COMPLICATIONS

Within 12 months in heart failure patients with secondary MR9

EXPAND TREATMENT OPTIONS
FOR SELECT HEART FAILURE PATIENTS

Results from the landmark COAPT™ trial established MitraClip therapy’s impact on heart failure patients with clinically significant secondary MR who remained symptomatic despite maximally tolerated guideline-directed medial therapy. By decreasing MR, patients experienced:

  • Improved survival7
  • Reduction in HF hospitalizations7
  • Improved quality of life10
  • At 3 years, MitraClip saves lives7
    Results from the landmark COAPT™ trial established MitraClip therapy’s impact on heart failure patients

    * Includes crossover patients (GDMT only patients that were allowed to crossover to MitraClip after 24 months).

    33%

    Relative mortality risk reduction

    .

    7.9

    # Needed to treat to prevent one death*

  • At 3 years, MitraClip reduces HF hospitalizations7


    Includes crossover patients (guideline-directed medical therapy [GDMT] only patients that were allowed to cross over to MitraClip after 24 months).

    51%

    Relative risk reduction in HF hospitalization2

    .

    3.0

    # Needed to treat to prevent 1 HF hospitalization2

  • MitraClip changes the course in patients’ quality of life10

    Note: Kansas City Cardiomyopathy Questionnaire (KCCQ) Minimum for Clinically Important Difference (MCID)=5 points; Large Improvement Defined as ≥20 Points in KCCQ from Baseline; quality of life is assessed only in surviving patients.
    A multicenter, randomized, controlled, parallel-group, open-label trial of transcatheter mitral valve repair (TMVr)* with the MitraClip device was conducted in symptomatic patients with heart failure and moderate-to-severe (grade 3+) or severe (grade 4+) secondary MR. Patients were randomized 1:1 to undergo TMVr with MitraClip and receive GDMT (n=302) or GDMT alone (n=312).8

    *TMVr is now also referred to as TEER (transcatheter edge-to-edge repair)

    2.5x

    More likely to experience a large improvement in quality of life with MitraClip

REAL-WORLD EXPAND STUDIES SHOW UNPARALLED CLINICAL OUTCOMES6

The EXPAND and EXPAND G4 studies were prospective, multi-center, single arm, international, post-market, real-world, observational studies of patients who received MitraClip NTR/XTR and MitraClip G4, respectively.6

  • ECL Adjudicated MR Severity6
    ECL Adjudicated MR Severity

    NOTE: Data not from head to head studies. Data differences depicted between these trials may not be directly comparable, statistically significant, or clinically meaningful due to differences in trial protocols, endpoints, and/or patient populations. Data provided for informational purposes only.

    .
     


    MR Reduction to ≤ Mild at 30 days achieved in 90.7% of subjects 95.9% had MR reduction to ≤ Moderate.

  • Statistically significant improvement in heart failure symptoms6,9

    80% of patients with NYHA I/II at 1 year in expand study9


    87% of patients with NYHA I/II at 30 days in expand G4 study6

  • Largest improvement in quality of life reported to date6,9

    EXPAND study 1 year9

    .
     

    21.6 POINTS
    IMPROVEMENT

    in KCCQ-OS at 1 year9

    EXPAND G4 study 30 days6

    .
     

    21 POINTS
    IMPROVEMENT

    in KCCQ-OS at 30 days6

MAT-2201455 v1.0 | Item approved for Global OUS use only.

References
  1. Feldman T. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation 5-Year Results of EVEREST II. Journal of American Collage of Cardiology. VOL . 66 , NO. 25, 2015.
  2. Kar S. Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. Heart 2018;0:1–7.
  3. Lim S. Five-Year Durability Results Of Transcatheter Mitral Valve Repair With the MitraClip® System in Patients With Severe Degenerative Mitral Regurgitation and Prohibitive Surgical Risk. Poster presented at ACC 2018.
  4. Feldman T. The EVEREST II REALISM Continued Access Study: Five-Year Outcomes in High Surgical Risk Patients. Data presented at PCR 2018.
  5. Feldman T. The EVEREST II REALISM Continued Access Non-High Risk Study: Mid- and Long-Term Follow-up in Surgical Candidates. Data presented at ESC 2017.
  6. Rodriguez E. Contemporary Outcomes with the MitraClip™ G4 System: Preliminary Results based on the EXPAND G4 Study. Data presented at TCT 2021.
  7. Mack M. COAPT: Three-Year Outcomes from a Randomized Trial of Transcatheter Mitral Valve Leaflet Approximation in Patients with Heart Failure and Secondary Mitral Regurgitation. Presented at TCT 2019.
  8. MitraClip G4 System Instructions for Use.
  9. Kar S. Core-Lab Adjudicated Contemporary Clinical Outcomes at 1 Year with MitraClip™ (NTR/XTR) System from Global EXPAND Study. Data presented at TCT 2020.
  10. Arnold SV et al. Health status after transcatheter mitral valve repair in heart failure and secondary mitral regurgitation. JACC Mar 2019, 25951; DOI: 10.1016/j.jacc.2019.02.010
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