The HeartMate 3 Left Ventricular Assist Device (LVAD) from Abbott has received U.S. Food and Drug Administration (FDA) approval 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 the 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 Source: AbbottSource: Abbottstage 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.

In developing the HeartMate 3 system, Abbott reduced the system's size and reimagined how blood passes through a heart pump. The HeartMate 3 pump utilizes technology known as Full MagLev (fully 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 a survival rate of 82.8% at two years, compared to 76.2% for patients implanted with the HeartMate II LVAD. Furthermore, rates of suspected pump thrombosis (clotting of blood) 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 New York Heart Association (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. Two-year data on the first 366 patients enrolled in the study were presented at the American College of Cardiology's (ACC) 67th Annual Scientific Session in March 2018 and simultaneously published in the New England Journal of Medicine.

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. The HeartMate 3 system received the CE Mark in Europe for both short-term and long-term support in October 2015 and U.S. FDA approval for short-term support in August 2017.

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