Indication and Important Safety Information Instructions for Use
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The Burden of MR

Mitral regurgitation (MR) is the most frequent valve disease in the United States1,2

NEARLY 1 IN 10 PEOPLE AGE 75 AND OLDER HAS MODERATE OR SEVERE MR.1,2

people group

(In comparison, 1 in 20 is affected by aortic valve disease.)

MR is a prevalent and progressive disease

MR initiates a cascade of events progressing to heart failure, then death, if left untreated.3,4

mortality cycle

There are 2 types of MR

Degenerative MR, also called primary or organic MR, is usually due to an anatomic abnormality of the mitral valve itself, including the leaflets and/or the subvalvular apparatus. It can be related to age, a birth defect, or underlying heart disease. According to the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease, transcatheter mitral valve repair (TMVr) with MitraClip® therapy may be considered for patients with severe degenerative MR who are not suitable for surgery.

Functional MR, also known as secondary MR, is the result of LV dilation, which can be secondary to ischemic heart disease. LV dysfunction leads to annular dilation and incomplete coaptation of the mitral valve, resulting in MR.

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Despite its prevalence, patients with moderate or severe MR are often undertreated

In 2009, only approximately 2% of the estimated 1.7 million patients with MR ≥ 3+ were treated with surgical intervention.1,6-9 Reasons for this include patients being considered too high risk for surgery and patient denial of surgical intervention. Updated 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease supports aggressive monitoring and early action, with the goal of preventing complications due to left ventricular (LV) volume overload.10

Nearly half of MR patients were denied surgery6*

high risk pie chart
Learn about a minimally invasive treatment option for your degenerative MR patients
References
  1. Lloyd-Jones D, Adams RJ, Brown TM, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2010 update: a report from the American Heart Association. Circulation. 2010;121(7):e46-e215.
  2. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011.
  3. Grigioni F, Tribouilloy C, Avierinos JF, et al; MIDA Investigators. Outcomes in mitral regurgitation due to flail leaflets: a multicenter European study. JACC Cardiovasc Imaging. 2008;1(2):133-141.
  4. Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, et al. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005;352(9):875-883.
  5. Cioffi G, Tarantini L, De Feo S, et al. Functional mitral regurgitation predicts 1-year mortality in elderly patients with systolic chronic heart failure. Eur J Heart Fail. 2005;7(7):1112-1117.
  6. Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28(11):1358-1365.
  7. Patel JB, Borgeson DD, Barnes ME, Rihal CS, Daly RC, Redfield MM. Mitral regurgitation in patients with advanced systolic heart failure. J Card Fail. 2004;10(4):285-291.
  8. Gammie JS, Sheng S, Griffith BP, et al. Trends in mitral valve surgery in the United States: results from the Society of Thoracic Surgeons Adult Cardiac Surgery Database. Ann Thorac Surg. 2009;87(5):1431-1439.
  9. Abbott Vascular data on file.
  10. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(22):2438-2488.

MitraClip® NT Clip Delivery System

INDICATION FOR USE
The MitraClip® NT 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.

CONTRAINDICATIONS
The MitraClip® NT Clip Delivery System is contraindicated in DMR patients with the following conditions:

  • Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen
  • 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® NT outside of the labeled indication. Treatment of non-prohibitive risk DMR patients should be conducted in accordance with standard hospital practices for surgical repair and replacement.
  • MitraClip® NT is intended to reduce mitral regurgitation. The MitraClip® NT procedure is recommended to be performed when an experienced heart team has determined that reduction of MR to ≤2+ is reasonably expected following the MitraClip® NT. If MR reduction to ≤2+ is not achieved, the benefits of reduced symptoms and hospitalizations, improved quality of life, and reverse LV remodeling expected from MitraClip® NT may not occur.
  • The MitraClip® NT Device 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. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury. Use universal precautions for biohazards and sharps while handling the MitraClip® NT System to avoid user injury.
  • Use of the MitraClip® NT should be restricted to those physicians trained to perform invasive endovascular and transseptal procedures and those trained in the proper use of the system.
  • The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and/or reuse may result in infections, malfunction of the device or other serious injury or death.

PRECAUTIONS

  • Patient Selection:
    • 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 calcified 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 DMR patients with an LVEF <20% or an LVESD >60mm. MitraClip® NT should be used only when criteria for clip suitability for DMR have been met.
    • The major clinical benefits of MitraClip® NT are reduction of MR to ≤2+ resulting in reduced hospitalizations, improved quality of life, reverse LV remodeling and symptomatic relief in patients who have no other therapeutic option. No mortality benefit following MitraClip® NT therapy has been demonstrated.
  • 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.
  • The heart team may determine an in-person surgical consult is needed to complete the assessment of prohibitive risk. The experienced mitral valve surgeon and heart team should take into account the outcome of this surgical consult when making the final determination of patient risk status.
  • For reasonable assurance of device effectiveness, pre-procedural evaluation of the mitral valve and underlying pathologic anatomy and procedural echocardiographic assessment are essential.
  • Note the “Use by” date specified on the package.
  • Inspect all product prior to use. DO NOT use if the package is opened or damaged, or if product is damaged.

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip® NT procedure.
Allergic reaction (anesthetic, contrast, Heparin, nickel alloy, latex); Aneurysm or pseudo-aneurysm; 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; Death; 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, MitraClip® NT Device); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClip® NT to the intended site; Failure to retrieve MitraClip® NT 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; MitraClip® NT erosion, migration or malposition; MitraClip® NT Device thrombosis; MitraClip® NT 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

Prior to use, please reference the Instructions for Use at www.abbottvascular.com/ifu for more information on indications, contraindications, warnings, precautions, and adverse events.