NEARLY 1 IN 10 PEOPLE AGE 75 AND OLDER HAS MODERATE OR SEVERE MR.1,2
(In comparison, 1 in 20 is affected by aortic valve disease.)
MR initiates a cascade of events progressing to heart failure, then death, if left untreated.3,4
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.
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
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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:
WARNINGS
PRECAUTIONS
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.