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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

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.

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. Von Bardeleben R.S., Contemporary Clinical and Echocardiographic Outcomes of 1000+ Patients Treated with MitraClip(TM) G4: Results from the EXPAND G4 Post Approval Study. Data Presented at 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. 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
  10. 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
Important Safety Information
  • MitraClip G4
  • MitraClip NTR/XTR

  • Rx Only

    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.

  • MITRACLIP CLIP DELIVERY SYSTEMS
    INDICATION FOR USE
     

    • The MitraClip™ NTR/XTR Clip Delivery 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™ NTR/XTR Clip Delivery System, when used with maximally tolerated guidelinedirected 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™ NTR/XTR Clip Delivery System is contraindicated in patients with the following conditions: Patients who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen, 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™ procedure: Death; Allergic reaction (anesthetic, contrast, Heparin, nickel alloy, latex); Aneurysm or pseudoaneurysm; Arrhythmias; Atrial fibrillation; Atrial septal defect requiring intervention; Arterio-venous fistula; Bleeding; Cardiac arrest; Cardiac perforation; Cardiac tamponade / Pericardial Effusion; Chordal entanglement / rupture; Coagulopathy; Conversion to standard valve surgery; Deep venous thrombus (DVT); Dislodgement of previously implanted devices; Dizziness; Drug reaction to anti-platelet / anticoagulation agents / contrast media; Dyskinesia; Dyspnea; Edema; Emboli (air, thrombus, MitraClipTM Implant); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClip™ to the intended site; Failure to retrieve MitraClipTM System components; Fever or hyperthermia; Gastrointestinal bleeding or infarct; Hematoma; Hemolysis; Hemorrhage requiring transfusion; Hypotension / hypertension; Infection; Injury to mitral valve complicating or preventing later surgical repair; Lymphatic complications; Mesenteric ischemia; MitraClipTM Implant erosion, migration or malposition; MitraClipTM Implant thrombosis; MitraClip™ System component(s) embolization; Mitral stenosis; Mitral valve injury; Multi-system organ failure; Myocardial infarction; Nausea /vomiting; Pain; Peripheral ischemia; Prolonged angina; Prolonged ventilation; Pulmonary congestion; Pulmonary thrombo-embolism; Renal insufficiency or failure; Respiratory failure / atelectasis / pneumonia; Septicemia; Shock, Anaphylactic or Cardiogenic; Single leaflet device attachment (SLDA); Skin injury or tissue changes due to exposure to ionizing radiation; Stroke or transient ischemic attack (TIA); Urinary tract infection; Vascular trauma, dissection or occlusion; Vessel spasm; Vessel perforation or laceration; Worsening heart failure; Worsening mitral regurgitation; Wound dehiscence.

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