FDA approves HeartMate 3 Left Ventricular Assist System for heart failure.-Abbott.

Abbott announced it has received FDA approval for its Full MagLev HeartMate 3 Left Ventricular Assist System (also known as an LVAD) for managing advanced heart failure patients in need of short-term hemodynamic support (bridge-to-transplant or bridge to myocardial recovery). The system also provides patients living with their device new benefits that embody the evolution of left ventricular assist device (LVAD) therapy, such as improved blood flow in a pump that uses full magnetic levitation to reduce trauma to blood passing through the system.

U.S. approval of the HeartMate 3 system was supported by the MOMENTUM 3 clinical study. In that study, patients who received a HeartMate 3 system had a significant improvement in their heart failure status, an 83 percent increase in their walk distance and a 68 percent improvement in quality of life at six months. Patients receiving HeartMate 3 also had an 86 percent survival rate with freedom from disabling stroke and reoperation to replace the pump at six months.