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Journal Articles

Journal Articles

The following journal articles help illustrate the clinical evidence for the HeartMate 3™ LVAD with Full MagLev™ Flow Technology:

First 5-year multicentric clinical trial experience with the HeartMate 3 Left Ventricular Assist System

Netuka I, Pya Y, Zimpfer D, Potapov E, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, PhD, Sood P, Gazzola C, Schmitto J. Journal of Heart and Lung Transplantation (2021) DOI: https://doi.org/10.1016/j.healun.2021.01.001.

Two-year outcome after implantation of a full magnetically levitated left ventricular assist device: results from the ELEVATE Registry

Zimpfer D, Gustafsson F, Potapov E, Pya Y, Schmitto J, Berchtold-Herz M, Morshuis M, Shaw S, Saeed D, Lavee J, Heatley G, Gazzola C, Garbade J; on behalf of the ELEVATE Investigators. European Heart Journal (2020) 41, pg. 3801–3809.

Multi-center, multi-national, observational registry. Enrollment of 540 consecutive patients in 26 centers. After 2-year follow-up post-implant ELEVATE demonstrates good 2-year survival and improvement in functional capacity and quality of life with the HeartMate 3 LVAS system in a real-world population. Low stroke rate and pump thrombosis rates are sustained up to 2 years. Low transplant rate (10%).

MOMENTUM 3: A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report

Final 2-yr follow-up of the full cohort (n=1,028 patients) looking at survival at 2 years free of disabling stroke (>3 mRS) or reoperation to replace or remove a malfunctioning device. Mehra, et al. NEJM 2019. DOI: 10.1056/NEJMoa1900486

The data from two-year follow-up of the MOMENTUM 3 full cohort demonstrates:

  • Clinical superiority of the HeartMate 3 LVAS when compared to the HeartMate II LVAS
  • Significantly less frequent rate for pump replacement with HeartMate 3 LVAS
  • Significantly lower rate of stroke and disabling stroke with HeartMate 3 LVAS
  • Significantly lower rate of GI bleeding with HeartMate 3 LVAS
  • Significantly lower rate of pump thrombosis with HeartMate 3 LVAS

Publications and Presentation from the MOMENTUM 3 Trial

A comprehensive list of the publications and presentations of analysis from the MOMENTUM 3 IDE trial and CAP study.

Momentum 3 Trial

Two-year results for the HeartMate 3 LVAD

The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) investigational device exemption (IDE) clinical study was designed to evaluate the safety and effectiveness of HeartMate 3 Left Ventricular Assist System (LVAS) by demonstrating non-inferiority to the HeartMate II™ LVAS when used for the treatment of advanced refractory left ventricular heart failure.

This device is commercially available for use in select international markets.

Indications, Safety & Warnings

MAT-2105188 v1.0

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