RECOMMENDED FOR
MORE PATIENTS. 

EXPANDED WITH 
GREATER COVERAGE.


2020 ACC/AHA Guidelines recommend TEER for Primary
and now, Secondary* MR Patients.

Medicare/CMS further expand their coverage to include patients with Secondary MR.  

DOWNLOAD 2020 ACC/AHA MR POCKET GUIDELINES

*Secondary MR patients despite optimal GDMT  

RECOMMENDED FOR
MORE PATIENTS. 

EXPANDED WITH 
GREATER COVERAGE.


2020 ACC/AHA Guidelines recommend TEER for Primary and now, Secondary* MR Patients.

Medicare/CMS further expand their coverage to include patients with Secondary MR.  

Download 2020 ACC/AHA MR Pocket Guidelines

*Secondary MR patients despite optimal GDMT  

2020 ACC/AHA GUIDELINES FOR VALVULAR HEART DISEASE RECOMMEND TEER FOR PRIMARY AND NOW, SECONDARY* MR PATIENTS

In December 2020, the American College of Cardiology (ACC) and American Heart Association (AHA) formally updated their clinical practice guidelines, incorporating recommendations for the use of transcatheter edge-to-edge repair (TEER) in primary mitral regurgitation patients who are at high or prohibitive risk as well as secondary patients. Per these guidelines, the MitraClip™ therapy is now classified as TEER.

A mitral transcatheter edge-to-edge repair is of benefit to patients with severely symptomatic primary mitral regurgitation who are at high or prohibitive risk for surgery, as well as to a select subset of patients with secondary mitral regurgitation who remain severely symptomatic despite guideline-directed management and therapy for heart failure.”1

TEER IS AN UPGRADED CLASS 2A RECOMMENDATION FOR SELECT PRIMARY MR PATIENTS 


Class 2A, LOE B-R

In severely symptomatic patients (NYHA class III or IV) with primary severe MR and high or prohibitive surgical risk, transcatheter edge-to-edge repair (TEER) is reasonable if mitral valve anatomy is favorable for the repair procedure and patient life expectancy is at least 1 year.

TEER IS A NEW CLASS 2A RECOMMENDATION FOR SELECT SECONDARY MR PATIENTS 


Class 2A, LOE B-NR

In patients with chronic severe secondary MR related to LV systolic dysfunction (LVEF < 50%) who have persistent symptoms (NYHA class II, III, or IV) while on optimal GDMT for HF (Stage D), TEER is reasonable in patients with appropriate anatomy as defined on TEE and with LVEF between 20% and 50%, LVESD ≤ 70 mm, and pulmonary artery systolic pressure ≤ 70 mm Hg.

These criteria, in conjunction with results of the COAPT trial, establish TEER as the standard of care for patients with symptomatic functional MR despite guideline-directed medical therapy who do not possess an alternative indication for cardiac surgery. 

Dr. Sammy Elmariah, MD, MPH
Massachusetts General Hospital

Effective by Design. Proven by Evidence.

The MitraClip™ therapy continues to advance care for those suffering from mitral regurgitation

We are proud to have contributed to these important guideline changes through the substantial body of prospective clinical evidence (both randomized and non-randomized) gathered over 17 years—demonstrating positive clinical outcomes with MitraClip™ and serving as the foundation for TEER recommendations for both primary mitral regurgitation (MR) and secondary MR.1

Over 17

Years of clinical
experience*

 

3 RCT'S

Demonstrating
Safety & Efficacy

OVER 30K

Patients studied
In clinical trials*

OVER 2500+

Publications

*Data On File at Abbott 

AND NOW, EXPANDED COVERAGE BY MEDICARE FOR SECONDARY MR PATIENTS

In January 2021, the U.S. Centers for Medicare & Medicaid Services (CMS) revised its National Coverage Determination (NCD) to expand coverage for transcatheter edge-to-edge repair (TEER), also referred to as transcatheter mitral valve repair (TMVr), to include patients with secondary (or functional) mitral regurgitation (MR) resulting from heart failure.

The decision significantly increases the number of people eligible for insurance coverage for mitral valve repair with MitraClipTM, enabling broader access to the first and only TEER device approved in the US.

Get additional details about the National Coverage Determination (NCD) announcement and expanded Medicare coverage.

VIEW THE NCD ANNOUNCEMENT

Learn more about the treatment for your MR patients that’s minimally invasive, formally recommended and now Medicare covered. 


MAT-2100687 v1.0 | Item approved for U.S. use only.

References

1. Otto C, et al. "2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines." J Am Coll Cardiol. Dec 17, 2020. Epublished DOI: 10.1016/j.jacc.2020.11.018.

† The testimonial does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual’s experience and might not be representative of others. 

Important safety information

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 regimen
  • 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

WARNINGS

  • DO NOT use MitraClip outside of the labeled indication.
  • The MitraClip™ G4 Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g. transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.
  • Read all instructions carefully. Use universal precautions for biohazards and sharps while handling the MitraClip™ G4 System to avoid user injury. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury including:
    • MitraClip™ G4 Implant erosion, migration or malposition
    • Failure to deliver MitraClip™ G4 Implant to the  intended site
    • Difficulty or failure to retrieve MitraClip™ G4 system components
  • Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClip™ in these patients has not been evaluated.
  • Patients with a rotated heart due to prior cardiac surgery in whom the System is used may have a potential risk of experiencing adverse events such as atrial perforation, cardiac tamponade, tissue damage, and embolism which may be avoided with preoperative evaluation and proper device usage.
  • For the Steerable Guide Catheter and Delivery Catheter only:
    • The Guide Catheter: the distal 65 cm of the Steerable Guide Catheter with the exception of the distal soft tip, is coated with a hydrophilic coating.
    • The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm.
    • Failure to prepare the device as stated in these instructions and failure to handle the device with  care could lead to additional intervention or serious adverse event.
  • The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and / or re-use may result in infections, malfunction of the device and other serious injury or death.
  • Note the product “Use by“ date specified on the package.
  • Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.

PRECAUTIONS

  • Prohibitive Risk Primary (or degenerative) Mitral Regurgitation
    • Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:
      • 30-day STS predicted operative mortality risk score of
        • ≥8% for patients deemed likely to undergo mitral valve replacement or
        • ≥6% for patients deemed likely to undergo mitral valve repair
    • Porcelain aorta or extensively calcifed ascending aorta.
    • Frailty (assessed by in-person cardiac surgeon consultation)
    • Hostile chest
    • Severe liver disease / cirrhosis (MELD Score > 12)
    • Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure)
    • Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery (IMA) at high risk of injury, etc.
    • Evaluable data regarding safety or effectiveness is not available for prohibitive risk Primary patients with an LVEF < 20% or an LVESD > 60 mm. MitraClip™ should be used only when criteria for clip suitability for Primary have been met.
    • The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.
  • Secondary Mitral Regurgitation
    • Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.
    • The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.

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 effusion
    • 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

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