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Percutaneous Mitral Value Repair

MitraClip Percutaneous Mitral Valve Repair System

 

 

Overview

Valves repaired. Lives improved.

Percutaneous mitral valve repair is expanding treatment options for patients suffering from the debilitating symptoms of mitral regurgitation (MR).

MitraClip is the world's first percutaneous mitral valve repair therapy available, providing an option for select patients with MR. Clinical evidence for MitraClip therapy demonstrates:1,2

Mitraclip

  • 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

 

 
1. Feldman T, Foster E, Qureshi M, et al. The EVEREST II Randomized Controlled Trial: Three Year Outcomes. Transcatheter Cardiovascular Therapeutics; October 22-26, 2012; Miami, FL.
2. Schillinger, W. ACCESS-EUROPE Phase I: A Post Market Study of the MitraClip System for the Treatment of Significant Mitral Regurgitation in Europe: Analysis of Outcomes at 1 Year. ESC 2012; August 25-29, 2012; Munich, Germany.

 

Product Overview

First-in-class Technology

Mitraclip

The MitraClip System is the first device available to safely perform percutaneous mitral valve repair.

  • 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

 

 

 

 

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

 

System Specifications

System Specifications

 

 

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.

Percutaneous mitral valve repair: The MitraClip procedure is minimally invasive and uses catheter-based technology. This new treatment expands the options for selected patients with MR. It has been shown to reduce MR, reverse left ventricular remodeling, improve NYHA functional class, and improve quality of life.5

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.
5. Feldman T, Foster E, Qureshi M, et al. The EVEREST II Randomized Controlled Trial: Three Year Outcomes. Transcatheter Cardiovascular Therapeutics; October 22-26, 2012; Miami, FL.

 

 

Clinical Trials

Clinical Trials

 

COAPT
The Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for Extremely High Surgical Risk Patients (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation in high surgical risk subjects. » more info

 

RESHAPE-HF
The RESHAPE-HF Trial is a randomized study to further study the safety and effectiveness of the MitraClip device in advanced heart failure patients with clinically significant functional mitral regurgitation. » more info

 

ACCESS Europe
ACCESS Europe is a post market observational study of the MitraClip system to gather information regarding health economics and clinical care in Europe. The study is now closed. » more info

 

REALISM
The REALISM study is a prospective, multi-center, continued access registry to collect new information regarding treatment of MR with the MitraClip system under more "real world" conditions, in addition to providing additional safety and effectiveness data. The study consists of two arms: a high risk arm and a non-high risk arm. This study is based in the United States and is currently enrolling patients in the high risk arm. » more info

 

EVEREST II
EVEREST II is a U.S. clinical study being conducted to assess the safety and efficacy (or effectiveness) of the MitraClip system for patients diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) MR. EVEREST II consists of a randomized arm and a High Risk Registry arm. The study is currently in follow-up phase. » more info

 

EVEREST I
Prospective, multi-center, Phase I study of the MitraClip System in the treatment of mitral valve regurgitation. The study is now closed. » more info

 

Clinical Evidence

 

Source:
Schillinger, W. ACCESS-EUROPE Phase I: A Post Market Study of the MitraClip System for the Treatment of Significant Mitral Regurgitation in Europe: Analysis of Outcomes at 1 Year. ESC 2012; August 25-29, 2012; Munich, Germany.

 

 

Find a PMVR Center

Find a PMVR Center

 

 

 

Download a list of PMVR centers in Europe, Middle East and Africa

For more information on MitraClip in Europe, Middle East and Africa, please email: EMEA.SH@av.abbott.com

 

 

 

 

 

Download a list of PMVR centers in Asia Pacific

 

 

 

 

 

 

PML04050 Rev. A

AP2938491-OUS Rev. A