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TENDYNE
MITRAL VALVE
REPLACEMENT
TRANSCATHETER MITRAL VALVE
REPLACEMENT (TMVR)

 

Tendyne™ TMVR System is first-in-class technology designed to eliminate Mitral Regurgitation (MR),
offering selected patients with MR (≥ grade 3) a novel 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 New York Heart Association (NYHA) 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

Quality time secured

Tendyne™ TMVR improves your patients’ function and quality of life, with clinically significant improvement in a 6-minute walk test2 and Kansas City Cardiomyopathy Questionnaire (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 comorbidities in this population.1
 

6-MINUTE WALK TEST2

KCCQ = Kansas City Cardiomyopathy Questionnaire

QUALITY OF LIFE1 - KCCQ SCORES

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 Mitral Valve Academic Research Consortium (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

BRINGING YOU...

Clinical case clubs | Educational tools | Hot topics
Expert opinions | Live & online discussions

 

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References
  1. Muller DWM, Sorajja P, Duncan A, 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. doi.org/10.1016/j.jacc.2021.08.060.
  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. doi.org/10.1016/j.jacc.2018.12.066.

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