Abbott Laboratories Receives FDA Approval For HeartMate 3 LVAD System

Abbott Laboratories received U.S. Food and Drug Administration approval for its full MagLev HeartMate 3 Left Ventricular Assist System (LVAD). The HeartMate 3 system provides advanced heart failure patients in need of short-term hemodynamic support and improved blood flow in a pump that uses full magnetic levitation to reduce trauma to blood passing through the LVAD system.

The decision by the FDA was supported by the Momentum 3 clinical study in which patients showed a significant improvement in their heart failure status, an 83% increase in their walk distance,a 68% improvement in quality of life at six months, and an 86% survival rate with freedom from disabling stroke and reoperation to replace the pump at six months.

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