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Percutaneous Mitral Valve Repair

MitraClip Percutaneous Mitral Valve Repair

Indications & Important Safety Information ›› IFU (Full Version) ››

  

 

Overview

Valves repaired. Lives improved.

Mitraclip

Now available in the United States, MitraClip therapy offers a treatment option with a favorable safety profile1 to significant, symptomatic, degenerative mitral regurgitation patients who are at prohibitive risk for surgery.


MitraClip is the world's first transcatheter mitral valve repair therapy available, providing an option for select patients with degenerative MR. Clinically important results in prohibitive-risk patients with degenerative mitral regurgitation demonstrate1,2:

  • Positive safety profile
  • Reduction in mitral regurgitation
  • Favorable left ventricular remodeling
  • Improvement in patient symptoms
  • Reduction in hospitalizations for heart failure

Click to play animation of the MitraClip procedure

TMVR Center

 
1.MitraClip Clip Delivery System Instructions for Use.
2.Data on file at Abbott Vascular.

 

 

Product Overview

First-in-class Technology

Mitraclip

MitraClip performs transcatheter mitral valve repair by creating a vertical line of coaptation, forming a double-orifice valve.

  • Beating-heart procedure with no cardiopulmonary bypass required
  • Allows for real-time positioning and repositioning to optimize mitral regurgitation reduction
  • Designed to preserve surgical options
  • Femoral venous access
  • Limited hospital length of stay
Steerable Guide Catheter

Steerable Guide Catheter

  • 24-French steerable catheter
  • Percutaneous venous access

Clip Delivery System

Clip Delivery System

The Clip Delivery System includes the implant attached to a highly maneuverable delivery catheter, with all controls at the proximal end.

Mitraclip Device

MitraClip Device

  • Cobalt chromium construction
  • Polyester cover designed to promote tissue growth
  • Magnetic resonance conditional to 3 tesla (T)*

     

    *Static magnetic field up to 3 T; maximum spatial gradient in static field of 2500 gauss/cm or less; maximum whole-body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning

 

 

About Mitral Regurgitation

About Mitral Regurgitation

Mitral regurgitation (MR) is a condition in which the heart's mitral valve leaflets do not close tightly. When this happens, blood flows backward from the heart's left ventricle into the left atrium. The heart must then work harder to push blood through the body, which can cause fatigue, shortness of breath and worsening heart failure.

There are two types of mitral regurgitation: degenerative and functional. Degenerative mitral regurgitation, also called primary mitral regurgitation, is caused by damage to the mitral valve leaflets. Functional mitral regurgitation, also called secondary mitral regurgitation, is caused by enlargement of the heart due to heart attack or heart failure.

MR is the most common type of heart valve insufficiency in the United States. Approximately 4 million people have significant mitral valve insufficiency, with an annual incidence of 250,000.1-3 Approximately 50,000 of these patients undergo surgery each year in the United States. Prevalence and incidence are similar in Europe, where it's the second most common type of heart valve disease.4 The disease affects millions of people worldwide.

Treatment Options for Mitral Regurgitation

Medical: There are no medications indicated to treat mitral regurgitation, but there are medications used to manage patient symptoms.

Surgical: For symptomatic patients diagnosed with moderate-severe or severe MR, surgery is generally recommended to repair or replace the mitral valve. This typically involves open-heart surgery with the patient on cardiopulmonary bypass. Patients recovering from mitral valve surgery may take several months to regain normal physical function and activity.

Transcatheter mitral valve repair: The MitraClip procedure is a minimally invasive catheter-based therapy. It is performed using venous access and real-time imaging thereby avoiding cardiopulmonary bypass. Patients generally recover within the post-procedure hospitalization and demonstrate improved functional capacity and quality of life. This treatment increases the options for patients with significant, symptomatic, degenerative MR who are at prohibitive risk for surgical intervention.

References:
1. US Census Bureau. Statistical Abstract of the US: 2006, Table 12.
2. Nkomo et al. Burden of Valvular Heart Diseases: A Population-based Study, Lancet, 2006; 368: 1005-11.
3. Patel et al. Mitral Regurgitation in Patients with Advanced Systolic Heart Failure, J of Cardiac Failure, 2004.
4. Iung, B et al. Eur Heart J. 2003;24:1231-1243.

 

 

 

AP2939260-US Rev. B

 

Indications and Important Safety Information

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MitraClip® Clip Delivery System

 

 

 

INDICATION FOR USE

The MitraClip 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 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 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 is intended to reduce mitral regurgitation.  The MitraClip 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.  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 may not occur.
  • The MitraClip 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 System to avoid user injury.
  • Use of the MitraClip 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.
  • Inspect all product prior to use.  DO NOT use if the package is opened or damaged.

 

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 should be used only when criteria for clip suitability for DMR have been met.
  • The major clinical benefits of MitraClip 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 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.
  • The inside of the outer pouch is not a sterile barrier. The inner pouch within the outer pouch is the sterile barrier. Only the contents of the inner pouch should be considered sterile. The outside surface of the inner pouch is NOT sterile.
  • Note the “Use by” date specified on the package. 

 

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip 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 Device); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClip to the intended site; Failure to retrieve MitraClip 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 erosion, migration or malposition; MitraClip Device 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

 

Mitraclip

 

   Steerable Guide Catheter

 

 

INDICATION FOR USE

The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

 

CONTRAINDICATIONS

  • Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen
  • Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.

 

WARNINGS

  • Read all instructions carefully. Failure to follow these instructions, warning and precautions may lead to device damage, user injury or patient injury. Use universal precautions for biohazards and sharps to avoid user injury.
  • Use the Steerable Guide Catheter 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.
  • The Steerable Guide Catheter is 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.
  • Patients with the following considerations in whom the Steerable Guide Catheter is used may have an increased risk of having a serious adverse event which may be avoided with preoperative evaluation and proper device usage.
    • Previous interatrial septal patch or prosthetic atrial septal defect (ASD) closure device which could result in significant difficulty in visualization or technical challenges during transseptal puncture and/or introducing the SGC into the left atrium.
    • Known or suspected unstable angina or myocardial infarction within the last 12 weeks could increase the procedural morbidity and mortality, due to increased hemodynamic stress secondary to general anesthesia.
    • Patients with active infection have an increased risk of developing an intraoperative and/or postoperative infection, such as sepsis or soft tissue abscess.
    • Known or suspected left atrial myxoma could result in thromboembolism and tissue injury due to difficulty with device positioning.
    • Recent cerebrovascular event (CVA) may increase the procedural morbidity associated with a transcatheter intervention, such as recurrent stroke.

 

PRECAUTIONS

NOTE the “Use by” date specified on the package.

 

Inspect all product prior to use. Do not use if package is opened or damaged.

 

The inside of the outer pouch is not a sterile barrier. The inner pouch within the outer pouch is the sterile barrier. Only the contents of the inner pouch should be considered sterile. The outside surface of the inner pouch is NOT sterile.

 

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.

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