MitraClip

MitraClip Is an
Established, Proven,
and Durable Therapy

Clinically Meaningful and Durable Outcomes with MitraClip

The longest, prospective follow up of patients with significant mitral regurgitation (MR) who were at prohibitive risk for surgery and were treated with MitraClip therapy shows that clinical benefits remain durable out to 5 years:1

  • 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

MR Severity at baseline, 1 Year, and 5 years1,*,†
 

The Power to Improve Cardiac Function and Achieve Reverse Remodeling

MR Severity at baseline, 1 Year, and 5 years1,*,†
 

LV end diastolic volume at baseline and 5 years1,†
 

*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.

  • Substantial Improvement in NYHA Class That Is Maintained Over the Long Term

    NYHA IMPROVEMENT AT BASELINE, 1 YEAR, AND 5 YEARS1
     

    NYHA IMPROVEMENT AT BASELINE, 1 YEAR, AND 5 YEARS1
     

  • IMPORTANT IMPROVEMENTS IN QUALITY OF LIFE SO PATIENTS CAN GET BACK TO LIVING LIFE SOONER

    FUNCTIONAL IMPROVEMENT IN 6-MINUTE WALK TEST (ACCESS-EU)2
     


    Reduction in hospitalization rate3
     


    Reduction in hospitalization rate3
     

Results Confirmed in the Real World

Results Confirmed in the Real World

Real-world clinical outcomes from the ACCESS-EU registry (N = 567) showed consistent results to those seen in the clinical study setting:2

  • A substantial portion of patients experienced a reduction in MR grade irrespective of etiology
    • 79% of patients with FMR and 75% of patients with DMR who received MitraClip therapy had MR grade of ≤2+ after a year post-surgery2
       
  • 70% of patients with FMR and 81% of patients with DMR had an NYHA class of ≤2 after 1 year (p < 0.0001)4

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 comorbidities5:

  • 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

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 comorbidities5:

  • 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

AP2947039-WBO Rev. A

References
  1. Feldman T, et al. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II. J Am Coll Cardiol. 2015;66(25):2844-2854.
  2. Maisano F, et al. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013;62(12):1052-1061.
  3. 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.
  4. Butter C, et al. Analysis of outcomes at 12 months by mitral regurgitation etiology in the ACCESS-EUROPE Phase I Study. Presented at EuroPCR. May 21-24, 2013. Paris, France.
  5. MitraClip NTR XTR Clip Delivery System Instructions for Use.
  6. Puls M, et al. One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry. Eur Heart J. 2016;37(8):703-712..
  7. Data on file at Abbott.

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