FDA Approves Abbott's HeartMate 3 LVAD

August 28, 2017—Abbott Vascular announced that it has received US Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 left ventricular assist device (LVAD) for the management of advanced heart failure patients in need of short-term hemodynamic support (bridge-to-transplant or bridge-to-myocardial recovery). The system also provides improved blood flow in a pump that uses full magnetic levitation to reduce trauma to blood passing through the system.

Abbott's HeartMate 3 system features a reduced size from previous generations and incorporated Full MagLev (fully magnetically levitated) flow technology that reduces trauma to the blood passing through the pump while optimizing blood flow. The purpose of this is that improved blood flow can help minimize complications, such as pump thrombosis, that can be associated with LVAD therapy, ultimately improving the patient's quality of life.

According to the company, FDA approval of the HeartMate 3 system was supported by the MOMENTUM 3 clinical study. The study includes more than 1,000 patients with New York Heart Association class IIIB or IV heart failure. Patients were followed for a short-term endpoint of 6 months and continue to be followed for a long-term endpoint of 2 years.

In the MOMENTUM 3 study, patients who received a HeartMate 3 system had a significant improvement in their heart failure status, an 83% increase in their walk distance, and a 68% improvement in quality of life at 6 months. Patients receiving HeartMate 3 also had an 86% survival rate with freedom from disabling stroke and reoperation to replace the pump at 6 months.

Mandeep R. Mehra, MD, commented in Abbott's announcement, "In the MOMENTUM 3 study, the HeartMate 3 system had no instances of suspected or established blood clotting within the pump at six months, which is a major milestone for those of us working tirelessly to improve clinical outcomes for patients living with advanced heart failure."

In October 2015, the HeartMate 3 system received CE Mark approval in Europe for both short-term and long-term support, advised Abbott Vascular.