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.

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