A BETTER EXPERIENCE FOR CLINICIANS, OUTSTANDING OUTCOMES1-5 FOR PATIENTS

HeartMate LVADs set the standard in heart failure LVAD therapy through innovation, experience and outstanding outcomes1-5. Our goal, like yours, is to keep patients with heart failure moving forward with the best possible quality of life. Read more to learn how HeartMate LVADs can help you achieve that goal, day in and day out.

Now Approved

HeartMate 3™ LVAD

Now approved for use in the United States, the HeartMate 3 LVAD represents a new milestone in therapy. Driven by Full MagLev™ Flow Technology, HeartMate 3 LVAD is designed to deliver better blood handling to provide improved patient outcomes.*

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HeartMate II™ LVAD

Over 25,000 patients with heart failure have received the HeartMate II LVAD, with some still on therapy for more than 10 years - making the HeartMate II LVAD the trusted pump with predictable performance and proven long-term patient outcomes.

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Abbott continues to set new standards with the world’s most comprehensive portfolio of innovative, evidence-based solutions for heart failure therapy supported by a deep commitment to the advancement of heart failure therapies.

*As defined by zero incidence of thrombus in the MOMENTUM 3 trial at 6 months. (MOMENTUM 3 = Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3).
†Abbott. Data on file, Report SJM-HM-1016_0032(1).

INDICATIONS AND IMPORTANT SAFETY INFORMATION

Rx Only
Brief Summary: Prior to using these devices, please review the User’s Manual 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-term hemodynamic support (e.g., bridge to transplant or bridge to myocardial recovery) in patients with advanced refractory left ventricular heart failure.

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.

Warnings: A thorough understanding of the technical principles, clinical applications, and risks associated with left ventricular support is necessary before using the HeartMate II Left Ventricular Assist System. Read the IFU before attempting implantation of the Left Ventricular Assist Device or before caring for HeartMate II patients. Completion of Abbott’s HeartMate II LVAD Surgical Training Program is also required prior to use. Understanding the operating and safety aspects of the HeartMate II Left Ventricular Assist System is critical for safe and successful use. All users, including clinicians, patients, and caregivers, must be trained on system operation and safety before use. All users, including clinicians, patients, and caregivers, must be trained on any HeartMate II power accessories (Power Module, Battery Charger, or HeartMate™ LVAD 14 Volt Lithium-Ion batteries) before use. Do not use the HeartMate II™ Left Ventricular Assist Device in pregnant women or in women likely to become pregnant. A growing fetus may dislodge the pump, which may result in device failure, catastrophic bleeding, or death. Instruct women of childbearing age to use reliable contraception if sexually active. Blood thinners have been associated with birth defects. Anticoagulation regimens are contraindicated during pregnancy. Certain parts of the HeartMate II Left Ventricular Assist System are not compatible with other HeartMate LVAS (such as the XVE Left Ventricular Assist System). Only use HeartMate II LVAS parts with the HeartMate II LVAS. Do not try to repair any of the HeartMate II system components. If components need service, contact appropriate personnel.
 
Please consult your doctor or the Abbott website for a complete list of risks.

Please refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.


References: 1. Mehra MR, Naka Y, Uriel N, et al; for the MOMENTUM 3 investigators. A fully magnetically levitated circulatory pump for advanced heart failure. N Engl J Med. 2017;376:440-450. 2. Park S. J., Milano, C. A., Tatooles, A. J., Rogers, J. G., Adamson, R. M., Steidley, D. E., et al (2012). Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circulation Heart Failure, 5(2), 241-248. 3. Maltais S., et al. PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study. J Heart Lung Transplant, 2017 Jan;36(1):1-12. Epub 2016 Nov 16. 4. Jorde, U. P., Kushwaha, S. S., Tatooles, A. J., Naka, Y., Bhat, G., Long, J. W., ... & Birks, E. J. (2014). 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). Journal of the American College of Cardiology, 63(17), 1751-1757. 5. Starling RC, Estep JD, Horstmanshof DA, Milano CA, et al; ROADMAP Study Investigators (2017). Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results. JACC Heart Fail, 2017 Mar 30.