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TMVR

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

Sustained mitral regurgitation (MR) elimination with Tendyne TMVR

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
 

Symptom improvement

NYHA Functional Class

Tendyne TMVR NYHA class improvement clinical data

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

Tendyne TMVR Walk Test

Quality of life1 - KCCQ Scores

Tendyne TMVR improved quality of life in clinical study

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

Clinically significant reduction in heart failure hospitalizations with Tendyne TMVR

*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,†:
 

Excellent procedural safety profile for Tendyne TMVR


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™ TMVR
CLINICAL TRIAL PROGRAM


Advancing TMVR therapy with clinical evidence

Tendyne TMVR Clinical Trial Program

MAT-2201634 v2.0 | Item approved for OUS use only.

References
  1. Muller D, et al. 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. J Am Coll Cardiol. 2021;78(19):1847-1859.
  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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