Tendyne™ Transcatheter
Mitral Valve Implantation

QUALITY TIME
SECURED

.

SUSTAINED MR ELIMINATION WITH TENDYNE

PREDICTABLE AND SUSTAINED CORRECTION OF MITRAL REGURGITATION

Most patients (98%) experienced immediate MR elimination at discharge and sustained MR elimination through 1 year.1

CHANGE IN MITRAL REGURGITATION1

CLINICALLY SIGNIFICANT SYMPTOM IMPROVEMENT

With Tendyne, patients can experience NYHA class improvement.

  • 88.5% of patients are in NYHA class I/II at 1 year versus 66.0% in class III/IV at baseline1

SYMPTOM IMPROVEMENT1
NYHA Functional Class
 

NYHA = New York Heart Association.

QUALITY TIME SECURED

Tendyne 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 test and KCCQ scores.1

6-Minute Walk Test1

Quality of Life1 - KCCQ Scores

KCCQ = Kansas City Cardiomyopathy Questionnaire.

72.4% survival rate at 1 year1

EXCEPTIONAL SAFETY PROFILE

Outstanding acute and 30-day outcomes

A technical success rate* of 96% was achieved, with low major adverse events1,†:

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 CLINICAL TRIAL PROGRAM

Clinical experience studying more than 300 patients over several years:

MAT-2000613 v2.0 | Item approved for OUS use only.

References
  1. Sorajja P, 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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