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CARDIOVASCULAR
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BREAKTHROUGH THERAPY FOR SELECT PATIENTS WITH MITRAL REGURGITATION

MitraClip is the world’s first transcatheter mitral valve repair (TMVr) therapy that delivers a treatment option for select patients with primary or secondary mitral regurgitation who would otherwise go untreated.1,2 Used in over 80,000 patients worldwide, MitraClip is a well-established procedure with a growing body of clinical and real-world experience.*

 

*Worldwide data as of March 2019, on file at Abbott.

MINIMALLY INVASIVE PROCEDURE

The MitraClip procedure is a minimally invasive catheter-based therapy performed by multidisciplinary Heart Teams.1 Open-heart surgery to repair or replace the mitral valve is generally recommended, but it is not an option for many patients. TMVr with MitraClip therapy delivers a treatment option for patients who are not good surgical candidates and would otherwise go untreated.1-3

Clinically important results in patients with mitral regurgitation (MR) demonstrate1,2:

  • Positive safety profile
  • Reduction in MR severity
  • Improvement in patient symptoms
  • Reduction in hospitalizations for heart failure
  • Short hospital length of stay
REFERENCES

1. MitraClip NTR XTR Clip Delivery System Instructions for Use.
2. Lim DS, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after the transcatheter mitral valve repair. J Am Coll Cardiol. 2014;64(2):182-192.
3. Nishimura RA, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135(25):e1159-e1195.

FIRST-IN-CLASS TECHNOLOGY

The MitraClip procedure is performed using venous access and real-time imaging (echocardiography and fluoroscopy), thereby avoiding cardiopulmonary bypass. The MitraClip device grasps and coapts the mitral valve leaflets, resulting in fixed coaptation (approximation) of the mitral leaflets throughout the cardiac cycle.1

  • Femoral venous access
  • Beating heart procedure—no cardiopulmonary bypass
  • Allows for real-time MR reduction assessment
  • Ability to reposition clip for optimal MR reduction
  • Designed to preserve surgical options

INNOVATIVE CLIP DELIVERY SYSTEM

The Clip Delivery System—introduced into the body through a Steerable Guide Catheter—includes the MitraClip device attached to a highly maneuverable delivery catheter, with all controls at the proximal end.1

MitraClip Delivery System

mitraclip

THE MITRACLIP DEVICE FEATURES1:

  • 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.

MORE OPTIONS, MORE POSSIBILITIES

We continue to innovate with the third generation of MitraClip, which allows you to treat your everyday cases and more complex cases with greater ease.*

  • MitraClip NTR: the original NT Clip size on an improved Clip Delivery System (CDS) is designed to be more precise and predictable through new ease-of-use features
  • MitraClip XTR: features longer Clip arms for easier grasping and better reach*,† on an improved CDS

Check with your Abbott Vascular representative for availability of these devices in your market.

 

 

MitraClip NTR and MitraClip XTR

Learn More About Our MitraClip Device Innovations

 

*Tests performed by and data on file at Abbott.
Performance of MitraClip XTR is in comparison to previous generation of MitraClip NT system.
This figure reflects the additional grasping width at 120º achieved with the MitraClip XTR Clip.

REFERENCES

1. MitraClip NTR XTR Clip Delivery System Instructions for Use.
2. Lim DS, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after the transcatheter mitral valve repair. J Am Coll Cardiol. 2014;64(2):182-192.

CLINICAL EFFECTIVENESS AND DEMONSTRATED SAFETY WITH MITRACLIP

Clinical study results demonstrate that treating mitral regurgitation (MR) with MitraClip therapy can deliver1,2:

  • Reductions in MR
  • Improved quality of life (NYHA Class)
  • Reductions in hospitalizations for heart failure (HF)

MITRACLIP OFFERS A SAFE TREATMENT OPTION FOR PATIENTS WITH MR

Clinical studies show intervention with MitraClip therapy safely reduces MR in patients despite being elderly with a high rate of serious comorbidities, or suffering from heart failure1:

In prohibitive-risk primary MR patients (lower than both mean or median predicted STS mortality risk for either repair or replacement)1
Within 12 months in heart failure patients with secondary MR1

REDUCTION IN HOSPITALIZATIONS FOR HF

MitraClip therapy reduces hospitalization in HF patients with secondary MR1:

A reduction in HF hospitalizations was reported in the 12 months post-MitraClip procedure from 12 months pre-MitraClip procedure in patients with primary MR2:

Reduction in hospitalizations for heart failure with MitraClip

COAPT TRIAL SHOWS SURVIVAL BENEFIT IN SELECT PATIENTS WITH SECONDARY MR

Results from the landmark COAPT Trial established the impact of MitraClip therapy on HF patients with clinically significant secondary MR who remain symptomatic despite maximally tolerated guideline-directed medial therapy (GDMT), including improved survival.1

CLINICALLY MEANINGFUL AND DURABLE OUTCOMES WITH MITRACLIP

The longest, prospective follow up of patients with significant mitral regurgitation (MR) who were candidates for mitral repair or replacement surgery and were treated with MitraClip therapy shows that clinical benefits remain durable out to 5 years3:

  • Reduction in MR severity
  • Reduction and stability of left ventricular (LV) volumes
  • Improvement in NYHA Functional Class

 

The Power to Improve Cardiac Function and Achieve Reverse Remodeling


Reduction in MR severity with MitraClip


Reduction in left ventricular volume with MitraClip

* In surviving patients with paired data.
†Everest Randomized Controlled Trial Conclusion: The final 5-year results of the EVEREST II trial supported the superiority of surgery in reducing MR but clearly supported the long-term safety of the MitraClip and the durability of MR reduction after percutaneous repair. Beyond 1 year, worsening MR and surgery for MV dysfunction occurred rarely after either surgery or percutaneous repair.

Short hospital length of stay

FAVORABLE SAFETY PROFILE

Study results demonstrate the safety of the MitraClip device despite the majority of patients being elderly with a high rate of serious comorbidities.1

  • Low procedural mortality rate of 6.3%
  • No elevated risk of mortality in patients who had the MitraClip procedure over non-surgical management
  • 18.9% of patients experienced a major adverse event at 30 days, with transfusion (12.6%) being the most common event
REFERENCES

1. MitraClip NTR XTR Clip Delivery System Instructions for Use.
2. Lim DS, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after the transcatheter mitral valve repair. J Am Coll Cardiol. 2014;64(2):182-192.
3. Feldman T, et al. Randomized comparison of percutaneous repair and surgery for mitralregurgitation: 5-year results of EVEREST II. J Am Coll Cardiol. 2015;66(25):2844-2854.
4. Armeni P, et al. Real-world cost effectiveness of MitraClip combined with medical therapy versus medical therapy alone in patients with moderate or severe mitral regurgitation. Int J Cardiol. 2016;209:153-160.
5. Data on file at Abbott.

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.