HeartMate 3 Left Ventricular Assist Device ( LVAD ) has received U.S. Food and Drug Administration ( FDA ) clearance as a destination therapy for people living with advanced heart failure.
With the approval, physicians can now offer the HeartMate 3 system to patients not eligible for a transplant who will live with their device for the rest of their lives.
More than 5.7 million Americans suffer from heart failure, and there are approximately 915,000 new patients diagnosed with the disease annually.
For advanced heart failure patients who can no longer rely on earlier stage treatment options, LVAD's take the workload off a weakened heart by pumping blood through the body, providing crucial, life-saving support for patients awaiting a heart transplant or for those not able to receive one.
The HeartMate 3 pump utilizes technology known as Full MagLev (f ully magnetically-levitated ) Flow, which reduces trauma to the blood passing through the pump while improving flow.
The HeartMate 3 system's U.S. approval was supported by clinical data from the MOMENTUM 3 trial.
During the study, patients with the HeartMate 3 LVAD had an unprecedented survival rate of 82.8% at two years.
Furthermore, rates of suspected pump thrombosis remained very low at 1.1% at two years.
The study also showcased the lowest-ever published stroke rate ( 10% ) for a continuous-flow LVAD at two years.
The MOMENTUM 3 study included more than 1,000 patients with NYHA Class IIIB or IV heart failure.
Patients were followed for a short-term endpoint of six months and a long-term endpoint of two years.
The HeartMate 3 system includes the LVAD pump as well as other components that help power and monitor the technology including an external, wearable controller and battery system. ( Xagena )
Source: FDA, 2018