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TEER

MitraClip Transcatheter 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, 7 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

1.3%

30-DAY
MORTALITY RATE

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

99%

FREEDOM FROM
DEVICE-SPECIFIC COMPLICATIONS

At 5 years in heart failure patients with secondary MR7

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 medical therapy.

  • Durable MR Reduction & Sustained Patient Safety
  • Earlier the Better, But Better Late than Never
  • Live Longer, Less Burdened
  • Durable MR Reduction & Sustained Patient Safety

    MITRACLIP™ SHOWS DURABLE MR REDUCTION OUT TO 5-YEARS


    At 5 years, 95% of MitraClip™-treated patients experienced MR≤2+, sustained from 93% at 30 days
     

    Primary Safety Endpoint: Sustained Through 5 Years

    Only 1% of MitraClip-treated patients (N=293) experienced device-specific safety events, with no new events after 30 days

    MITRACLIP IMPLANT ATTEMPTS (N=293)

    30 DAYS

     

    12 MONTHS

     

    24 MONTHS

     

    36 MONTHS

     

    48 MONTHS

     

    60 MONTHS

     

    All safety events (%)4 (1.4)9 (3.3)13 (5.2)20 (8.8)22 (10.1)23 (10.8)
    Device-specific events  (%)4 (1.4)4 (1.4)4 (1.4)4 (1.4)4 (1.4)4 (1.4)

    -SLDA

    		2 (0.7)2 (0.7)2 (0.7)2 (0.7)2 (0.7)2 (0.7)

    -Device embolization

    		1 (0.3)1 (0.3)1 (0.3)1 (0.3)1 (0.3)1 (0.3)

    -Endocarditis requiring surgery

    		0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)

    -Mitral stenosis requiring* surgery

    		0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)

    -Any device-related complication requiring non-elective CV surgery

    		1 (0.3)1 (0.3)1 (0.3)1 (0.3)1 (0.3)1 (0.3)
    Progressive HF unrelated to device complications0 (0.0)5 (2.0)9 (3.8)16 (7.5)18 (8.8)19 (9.5)
    -LVAD0 (0.0)3 (1.2)6 (2.6)11 (5.1)12 (5.8)13 (6.5)
    -Heart transplantation0 (0.0)2 (0.8)3 (1.3)7 (3.4)9 (4.7)9 (4.7)

    SLDA = single leaflet device attachment. LVAD = left ventricular assist device. *Mitral valve area <1.5 cm2 by echo core laboratory measurement.

  • Earlier the Better, But Better Late than Never

    Treatment with MitraClip™ in control patients was an independent predictor of freedom from subsequent heart-failure hospitalization (HFH) or death.

    Even after two years, crossover subjects* experienced outcomes similar to those initially in the device group; however, nearly half of the control group patients had died by the time crossover was permitted, emphasizing the need for early treatment with the MitraClip™ therapy.

    * Crossover subjects: COAPT Protocol permits crossover MitraClip treatment of severe mitral regurgitation in control group patients after 2 years. For crossover patients, follow-up duration is from the crossover procedure date.

  • Live Longer, Less Burdened

    MitraClip™ + GDMT patients were more likely to be in NYHA functional class I or II throughout the 5 years


    * Data in the GDMT alone group includes those patients who crossed over to the MitraClip device.

    MitraClip™ + GDMT patients benefited from a 47% relative risk reduction in HFH/ Death versus GDMT-alone7

REAL-WORLD EXPAND STUDIES SHOW UNPARALLED CLINICAL OUTCOMES6,9

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.6,9

  • ECL Adjudicated MR Severity6

    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 91% of subjects 98% 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


    83% 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

    .
     

    18 POINTS
    IMPROVEMENT

    in KCCQ-OS at 30 days6

MAT-2201455 v4.0 | Item approved for 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 Study: Mid- and Long-Term Follow-up in Surgical Candidates. Data presented at ESC 2017.
  6. Von Bardeleben et al. Contemporary Outcomes of 1000+ Patients Treated with MitraClip™ G4: Results from the EXPAND G4 Post Approval Study. Data presented TCT 2022.
  7. Stone GW. et al. Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. March 5, 2023. DOI: 10.1056/NEJMOA2300213
  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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