*Based on HeartMate 3™ LVAD highest published survival and lowest published stroke and thrombosis rates in continuous-flow LVAD category of devices in the U.S.1-4
** HeartMate 3 LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.
***Ongoing evaluation of more than 2,000 patients on short- and long-term therapy of devices in the U.S.1,9,10,11
†For a continuous-flow LVAD in a randomized controlled trial.
††Key adverse events include pump thrombosis, stroke and gastrointestinal bleeding.
Indications and Important Safety Information
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.
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.
Contraindications: The HeartMate 3™ Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulationtherapy.
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.
References: 1. Mehra M, Uriel N, Naka Y, et al. A Fully Magnetically Levitated Ventricular Assist Device-Final Report. N Engl J Med. 2019;380:1618-1627. 2. Rogers JG, Pagani F, Tatooles A, et al. Intrapericardial left ventricular assist device for advanced heart failure. New Engl J Med. 2017;376:451-460. 3. Markham DW. Two-year Outcomes in the ENDURANCE Supplemental Trial. American Heart Association (AHA) Annual Meeting; November 10, 2018; Chicago, IL. 4. Uriel N. Long-Term Burden of Hemocompatibility Related Adverse Events in the MOMENTUM 3 Trial: Final Analysis of the 1028 Patient Cohort. The International Society for Heart & Lung Transplantation (ISHLT) Annual Meeting; April 4, 2019; Orlando, FL. 5. Bourque K, Cotter C, Dague C, et al. Design rationale and preclinical evaluation of the HeartMate 3 Left Ventricular Assist System for hemocompatibility. Am Soc Artificial Int Organs. 2016;62:375-383. 6. Bourque K, Dague C, Farrar D, et al. In vivo assessment of a rotary left ventricular assist device-induced artificial pulse in the proximal and distal aorta. Artificial Organs. 2006;30:638-642. 7. Abbott. Data on File. 8. Mehra MR. A Fully Magnetically Levitated Left Ventricular Assist Device-Final Report for the MOMENTUM 3 Trial. American College of Cardiology (ACC) Annual Meeting; March 17, 2019; New Orleans, LA. 9. Khush KK, Cherikh WS, Chambers DC, et al. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-fifth Adult Heart Transplant Report-2018; Focus Theme: Multiorgan Transplantation. J Heart Lung Transplant. 018;37:1155-1168. 10. Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241-2251. 11. Jorde UP, Kushwaha SS, Tatooles AJ, et al. Results of the destination therapy post-Food and Drug Administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS‡ registry (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. 2014;63:1751-1757.
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