TENDYNE™ TRANSCATHETER MITRAL VALVE REPLACEMENT CLINICAL DATA
Tendyne™ TMVR System is first-in-class technology designed to eliminate mitral regurgitation (MR), offering select patients with MR (≥ grade 3), a minimally invasive option for mitral valve replacement.
SUSTAINED MR ELIMINATION WITH TENDYNE™ TMVR
Predictable and sustained correction of Mitral Regurgitation
through 2 years
Change in Mitral Regurgitation1
CLINICALLY SIGNIFICANT SYMPTOM IMPROVEMENT
With Tendyne™ TMVR, patients can experience NYHA (New York Heart Association) class improvement. 81.6% of patients are in NYHA class I/II at 2 years versus 66.0% in class III/IV at baseline.1
NYHA Functional Class
QUALITY TIME SECURED
Tendyne TMVR improves your patients' 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.
CLINICAL TRIAL PROGRAM
Advancing TMVR therapy with clinical evidence
MAT-2201634 v2.0 | Item approved for OUS use only.