MOMENTUM 3 is the largest LVAD trial ever conducted demonstrating unprecedented** survival and safety outcomes with HeartMate 3™ LVAD.†1 The Continuing Access Protocol (CAP) was published in 2021 and extends the post-pivotal trial period for an additional 2 years in 1685 patients.2
Based on published data from multicenter experience and separate studies, which may involve different patient populations and other variables. Not a head-to-head comparison. Data presented for informational purposes only.
| NYHA Class | Class III | Class IIIB | CLASS IV (AMBULATORY) |
Class IV (ON INOTROPES) |
|||
|---|---|---|---|---|---|---|---|
| Markedly symptomatic during daily activities, asymptomatic only at rest | Severe limitations, symptoms even at rest | ||||||
| Intermacs‡ Profiles | 7 | 6 | 5 | 4 | 3 | 2 | 1 |
| Advanced NYHA III symptoms | Exertion limited | Exertion intolerant | Resting symptoms | Stable but inotrope dependent | Progressive decline on inotropic support | Critical cardiogenic shock | |
| I | IV Inotropes |
|---|---|
| N | NYHA IIIB/IV or persistently elevated natriuretic peptides |
| E | End-organ dysfunction (Cr > 1.8 mg/dL or BUN > 43 mg/dL) |
| E | EF ≤ 35% |
| D | Defibrillator shocks |
| H | Hospitalizations > 1 with heart failure |
| E | Edema (or elevated PA pressure) despite escalating diuretics |
| L | Low blood pressure, higher heart rate |
| P | Prognostic medication — progressive intolerance or down-titration GDMT |
*Compared with HeartMate II LVAD.
**Based on HeartMate 3 LVAD highest published survival and lowest published stroke and thrombosis rates in a randomized controlled trial for continuous-flow LVAD category of devices in the U.S.1,3,5,6
†HeartMate 3 LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.
‡ Indicates a third-party trademark, which is property of its respective owner.
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
HeartMate 3™ LVAS Indications: The HeartMate 3™ Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.
HeartMate 3™ LVAS Contraindications: The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.
HeartMate 3™ LVAS Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or pump thrombosis.
MAT-2012011 v2.0
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Unless otherwise specified, all product and service 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.
Precautions
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
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