VASCULAR
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A TECHNOLOGICAL BREAKTHROUGH FOR PATIENTS WITH MITRAL REGURGITATION.

MitraClip therapy is the world’s first transcatheter mitral valve repair that delivers a therapeutic option when no other option exists1. Used in over 50,000 patients worldwide, MitraClip is a well-established therapy with a growing body of clinical and real-world experience2.

Clinically important results in patients with mitral regurgitation demonstrate1,3:

  • Positive safety profile
  • Reduction in mitral regurgitation
  • Improvement in patient symptoms
  • Reduction in hospitalizations for heart failure

 

Click to play animation of the MitraClip procedure

1. Final Results of the Feldman T. Final Results of the EVEREST II Randomized Controlled Trial of Percutaneous and Surgical Reduction of Mitral Regurgitation. Presentation at ACC Scientific Sessions; March, 2014; Washington, DC.
2. Worldwide data as of August 2017, on file at Abbott.
3. Data on file at Abbott.

FIRST-IN-CLASS TECHNOLOGY

MitraClip System

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

MitraClip Steerable Guide Catheter

STEERABLE GUIDE CATHETER

  • 24-French steerable catheter
  • Percutaneous venous access

MitraClip 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 NT 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

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.

About Mitral Regurgitation

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.

 

AP2938491-WBO Rev. B

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