A BETTER EXPERIENCE FOR CLINICIANS, OUTSTANDING OUTCOMES FOR PATIENTS1-5

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 DT APPROVED

HeartMate 3™ LVAD

Now approved for both Destination Therapy (DT) and Bridge to Transplant (BTT) in the United States.  The HeartMate 3 LVAD delivers unprecedented long-term survival and safety outcomes as demonstrated in the MOMENTUM 3 Trial at 2 years*1

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HeartMate II™ LVAD

Over 26,600 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.6

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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.

† Based on HeartMate™ LVAD highest published survival and lowest published stroke and thrombosis rates in continuous-flow LVAD category of devices in the U.S.1,4,5,7,8
*HeartMate 3™ LVAD demonstrated superiority in event-free survival (primary endpoint) in the MOMENTUM 3 trial compared to HeartMate II™ LVAD.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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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 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 include, but are not limited to those 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 pump pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and pump thrombosis.

References: 1. Mehra MR, Goldstein DJ, Uriel N, et al. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018;378(15):1386-1395. 2. Park SJ, Milano CA, Tatooles AJ, Rogers, et al.  Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail.  2012;5:241-248. 3. Maltais S, Kilic A, Natha S, et al.  PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study. J Heart Lung Transplant.  2017;36:1-12. 4. 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. 5. Starling RC, Estep JD, Horstmanshof DA, et al. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results. J Am Coll Cardiol HF. 2017;5:518-527.  6. Abbott. Data as of May 11, 2018 on file. SJM-HM-1016-0032(3)  7. Rogers JG, Pagani FD, Tootles AJ, et al. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017;376,451-60.  8. Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow ventricular assist device. N Engl J Med. 2009;361:2241-2251.