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

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 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 OUTCOMES6,10

The EXPAND and EXPAND G4 studies are prospective, multi-center, single arm, international, post-market, real-world, observational studies of patients who received MitraClip NTR/XTR and MitraClip G4, respectively.6,10
 

ECL Adjudicated MR Severity

MR Reduction to ≤ Mild at 30 days achieved in 91% of subjects and 98% had MR reduction to ≤ Moderate6

NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

SEE MORE CLINICAL EVIDENCE BY VISITING MITRACLIP.COM

Learn more

 MAT-2115179 v5.0 | Item approved for U.S. use only.

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