Tendyne™ TMVI

QUALITY TIME
SECURED

.

SUSTAINED MR ELIMINATION WITH Tendyne™ TMVI

PREDICTABLE AND SUSTAINED CORRECTION OF MITRAL REGURGITATION THROUGH 2 YEARS

CHANGE IN MITRAL REGURGITATION1

CLINICALLY SIGNIFICANT SYMPTOM IMPROVEMENT

With Tendyne™ TMVI, patients can experience NYHA class improvement.

  • 81.6% of patients are in NYHA class I/II at 2 years versus 66.0% in class III/IV at baseline1

SYMPTOM IMPROVEMENT1
NYHA Functional Class

NYHA = New York Heart Association.

QUALITY TIME SECURED

Tendyne TMVI is a breakthrough therapy providing your high-risk patients improvement in function and quality of life, with clinically significant improvement in a 6-minute walk test2 and KCCQ scores.1

The 2-year all-cause mortality rate of 39% is an acceptable mid-term safety profile considering the advanced age and underlying comorbities in this population.1

6-Minute Walk Test2

Quality of Life1 - KCCQ Scores

KCCQ = Kansas City Cardiomyopathy Questionnaire.

CLINICALLY SIGNIFICANT REDUCTION IN HEART FAILURE HOSPITALIZATIONS

Assessed over a 6-month duration both before and after the procedure, heart failure hospitalizations were reduced by nearly 50% per patient-year.1

HEART FAILURE HOSPITALIZATION RATE
 

*in the 6 months pre- and post-procedure

Excellent Procedural SAFETY PROFILE

Outstanding acute and 30-day outcomes

A technical success rate* of 96% was achieved, with low major adverse events2,†:

STS PROM = Society of Thoracic Surgeons Predicted Risk of Mortality.

*Technical success per MVARC.
Major adverse events adjudicated by an independent clinical events committee.
In the entire cohort, only 1 episode of major apical bleeding occurred in a case in which implantation was aborted and no apical pad remained implanted at the access site.

Tendyne™ TMVI CLINICAL TRIAL PROGRAM

Clinical experience studying more than 300 patients over several years:

MAT-2000613 v4.0 | Item approved for Global OUS use only.

References
  1. Muller, D. Two-Year Outcomes of Tendyne Transcatheter Mitral Valve Implantation to Treat Symptomatic, Severe Mitral Regurgitation. David Muller. Presented at: PCR E-Course, June, 2020.
  2. Sorajja P, Moat N, Badhwar V, et al. Initial feasibility study of a new transcatheter mitral prosthesis: the first 100 patients. J Am Coll Cardiol. 2019;73(11):1250-1260.

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