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
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.
- 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.