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TEER

MITRACLIP™ TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) CLINICAL DATA

MitraClip TEER is the standard of care in transcatheter mitral valve repair (TMVr) that delivers meaningful innovation and provides unmatched, clinically proven reductions in MR – making a difference in the lives of more than 300,000 patients worldwide.

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 improve quality of life and relieve heart‑failure symptoms.
Clinical studies show that MitraClip TEER, can safely reduce MR in select patients, including those who are older or have significant comorbidities such as heart failure.3

1.3%

30-DAY
MORTALITY RATE

Evaluating contemporary real-world clinical outcomes in patients treated with MitraClip G4 system1

99%

FREEDOM FROM
DEVICE-SPECIFIC COMPLICATIONS

At 5 years in heart failure patients with secondary MR2

MITRACLIP TEER SETS THE BAR WITH DEMONSTRATED POSITIVE CLINICAL OUTCOMES IN A REAL-WORLD CONTEMPORARY SETTING1

EXPAND G4 Study was a prospective, international, multi-center, single arm, post-market, real world, observational study, with outcomes independently assessed by an Echocardiographic Core Laboratory (ECL).

  • Significant and sustained improvement in MR reduction1

    EXPAND G4 30 day and 1-year outcomes


    MR Reduction to 
    ≤ Mild at 30 days achieved in 91% of subjects; 98% had MR reduction to 
    ≤ Moderate.

  • Statistically significant improvement in heart failure symptoms1,4

    82% of patients with NYHA I/II at 2 years in EXPAND G4 study4

  • Large improvement in quality of life1

    EXPAND G4 Study 2 years4


    17 POINT
    IMPROVEMENT

    in KCCQ-OS score
    at 2 years4
     

DURABILITY MEANS YEARS, NOT MONTHS

Results from the landmark COAPT™ trial established MitraClip™ TEER 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 safety2

    MitraClip shows durable MR reduction out to 5 years2


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

    Primary Safety Endpoint: Sustained Through 5 Years2

    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)
    -SLDA2 (0.7)2 (0.7)2 (0.7)2 (0.7)2 (0.7)2 (0.7)
    -Device embolization1 (0.3)1 (0.3)1 (0.3)1 (0.3)1 (0.3)1 (0.3)
    -Endocarditis requiring surgery0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
    -Mitral stenosis requiring* surgery0 (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 surgery1 (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.

  • The Earlier the Better, But Better Late than Never2

    Earlier treatment with MitraClip therapy saves lives, but also, it’s never too late to improve patient outcomes.2

     

    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.

    *For crossover patients, follow-up duration is from the crossover procedure date.

  • Live Longer, Less Burdened

    MitraClip™ + GDMT patients benefited from a 47% relative risk reduction in HFH/ Death versus GDMT-alone2

 MAT-2675488 v1.0 | Item approved for U.S. use only.

References
  1. 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.
  2. 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
  3. MitraClip G5 System Instructions for Use.
  4. De Marco F., et al. Two-Year Outcomes with the MitraClip G4 System: Results from the EXPAND G4 Study. Data presented at PCR London Valves 2025.
Important Safety Information
  • MitraClip G5

  • Rx Only

    MITRACLIP™ CLIP DELIVERY SYSTEM

    INDICATIONS FOR USE

    The MitraClip™ G5 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™ G5 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™ G5 System is contraindicated for use in patients with the following conditions:

    • Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation
    • Untreatable hypersensitivity to Implant components (nickel- titanium alloy, cobalt-chromium alloy)
    • Active endocarditis or other active infection of the mitral valve 

    POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

    The following events have been identified as possible complications of the MitraClip™ G5 procedure:
    Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials, and drug reactions to anticoagulation, or antiplatelet drugs, additional treatment/surgery from device-related complications, atrial septal defect, bleeding, blood disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)), Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias), Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, unstable angina, and stable angina), Cardiac perforation, Cardiac tamponade, chest pain, death, Dyspnea, Edema, Embolization (device or components of the device), Endocarditis, fever or hyperthermia, Fluoroscopy and Transesophageal echocardiogram (TEE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding, Hypotension / hypertension; Infection including: Septicemia; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single leaflet device attachment (SLDA), dislodgement of previously implanted devices, tissue damage, mitral valve stenosis, worsening, persistent or residual regurgitation, nausea or vomiting, pain, Pericardial effusion, stroke / cerebrovascular accident (CVA) and transient ischemic attack (TIA), system organ failure: cardio-respiratory arrest, worsening heart failure, Pulmonary congestion, Respiratory dysfunction or failure or atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic), Thrombosis, Vascular access complications which may require additional intervention, including: wound dehiscence, bleeding of the access site, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation (rupture), vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury, Venous thrombosis (including deep vein thrombosis) and thromboembolism (including pulmonary embolism)

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