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Indications and Important Safety Information

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Brief Summary: Prior to using these devices, please review the Instructions for Use (IFU) for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The HeartMate 3 LVAD is intended to provide hemodynamic support in patients with advanced refractory left ventricular heart failure for short-term support, such as bridge to cardiac transplantation (BTT) or myocardial recovery. The HeartMate 3 LVAS is intended for use inside or outside the hospital, or for transportation of LVAD patients via ground ambulance, airplane, or helicopter.

Contraindications: The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 Left Ventricular Assist System are listed below. Adverse events are listed in decreasing order of frequency, except for death, which appears first because it is a non-reversible complication: Death, bleeding (perioperative or late), cardiac arrhythmia, local infection, respiratory failure, device malfunction, sepsis, right heart failure, driveline or pump pocket infection, renal failure, stroke, neurologic dysfunction, psychiatric episode, peripheral thromboembolic event, hemolysis, hepatic dysfunction, device thrombosis myocardial infarction.

Warnings: A thorough understanding of the technical principles, clinical applications, and risks associated with left ventricular support is necessary before using the HeartMate 3 Left Ventricular Assist System. Read the IFU before attempting implantation of the Left Ventricular Assist Device or before caring for HeartMate 3 patients. Completion of Thoratec’s HeartMate 3 LVAD Surgical Training Program is also required prior to use. Understanding the operating and safety aspects of the HeartMate 3 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 3 power accessories (Power Module, Battery Charger, or HeartMate™ 14 Volt Lithium-Ion batteries) before use. Do not use the HeartMate 3 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 3 Left Ventricular Assist System are not compatible with other HeartMate systems (such as the XVE Left Ventricular Assist System). Only use HeartMate 3 parts with the HeartMate 3 system. Do not try to repair any of the HeartMate 3 system components. If components need service, contact appropriate personnel. Please consult your doctor or the St. Jude Medical website for a complete list of risks.

Please refer to the Instructions for Use for detailed indications, contraindications, warnings, precautions and potential adverse events. 

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