A left ventricular assist device (LVAD) is a pump for patients with advanced heart failure. Once implanted, the LVAD is designed to help the left ventricle of your patient’s heart pump blood to the rest of their body. LVADs can be used as bridge-to-transplant therapy and/or destination therapy. LVADs are an important therapy option for patients with Class IIIB or IV heart failure. The left ventricular assist device system you choose for placement can impact your patient's quality of life.
The HeartMate 3™ Left Ventricular Assist Device is indicated for short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure. HeartMate 3 LVAD with Full MagLev™ Flow Technology delivers unprecedented* survival and safety outcomes as demonstrated in the MOMENTUM 3 Trial at 2 years.1**
The HeartMate II™ LVAD is designed to provide short- or long-term circulatory support for advanced heart failure patients and is indicated for both destination therapy and bridge-to-transplantation in the United States. Backed by more than 10 years of data, the HeartMate II LVAD is the most widely used and extensively studied LVAD in the world, with more than 27,000 patients implanted worldwide.2,3
For a complete listing of potential adverse events, please see the HeartMate II and HeartMate 3 LVADs Adverse Events section listed below.
*Based on HeartMate 3™ LVAD highest published survival and lowest published stroke and thrombosis rates in a randomized controlled trial in the continuous-flow LVAD category of devices in the U.S.1,2-6
**HeartMate 3™ LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.
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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 II™ LVAS Indications: The HeartMate II Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.
HeartMate 3™ and HeartMate II™ LVAS Contraindications: The HeartMate 3 and HeartMate II Left Ventricular Assist Systems are contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.
HeartMate 3™ and HeartMate II™ LVAS Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System are listed below: 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) and possible pump thrombosis.
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