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

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

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.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.

TENDYNE™ TMVR
CLINICAL TRIAL PROGRAM


Advancing TMVR therapy with clinical evidence

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

Copyright © 2022 Abbott, 3200 Lakeside Dr, Santa Clara, 95054, U.S.A.
Caution: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos on file at Abbott.
Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates.
No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

MAT-2000631 v10.0 | Item approved for OUS use only.

YOU ARE ABOUT TO ENTER AN ABBOTT COUNTRY OR REGION SPECIFIC WEBSITE.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of the product that are not approved in other countries or regions.

YOU ARE ABOUT TO LEAVE
www.structural­heart.abbott

You are now leaving www.structuralheart.abbott. Abbott is not responsible for any content published on the third-party website you are about to enter. Abbott has not reviewed and does not endorse any information presented on third-party websites.