REFERENCE
*This testimonial relates an account of an individual's response to the treatment. This patient's account is genuine, typical and documented, however, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.
IMPORTANT SAFETY INFORMATION
Rx Only
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 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.
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 anticipated decreasing order of frequency, except for death, which appears first as it is a non-reversible complication: Death, Bleeding, Cardiac Arrhythmia, Localized Infection, Device Malfunctions, Right Heart Failure, Respiratory Failure, Driveline Infection, Sepsis, Renal Dysfunction, Other Neurological Event (not stroke-related), Stroke, Hypertension, Psychiatric Episode, Venous Thromboembolism, Hepatic Dysfunction, 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 Pump Thrombosis.
Please refer to the HeartMate 3 Left Ventricular Assist System Instructions for Use for additional warnings and precautions.
Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical/Abbott or one of its subsidiaries.
