Heart failure has devastating consequences in the United States and while the average age of patients is much higher, it can affect the lives of children and their families. For many types of pediatric heart failure patients, receiving a heart transplant is the gold standard in care. While waiting for a heart transplant, some children may require a left ventricular assist device (LVAD) to support their heart until a donor heart is available. In addition, children who are not current candidates for heart transplantation may receive an LVAD to allow the child to resume a sense of normal life.
The small, 2 inch in diameter HeartMate 3™ LVAD has been approved as a short-term therapy for adult patients with advanced heart failure since 2017 and was approved for long-term use in 2018. The HeartMate 3 was approved for use in pediatric patients in 2020, and is the latest innovation in LVAD therapy.
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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.
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, anticoagulation therapy.
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.
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