US FDA approve HeartMate 3 heart pump advanced heart failure patients not eligible for a heart transplant

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HeartMate 3

The HeartMate 3 left ventricular assist device has received US 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 their device for the rest of their lives. For advanced heart failure patients who can no longer rely on earlier stage treatment options, a press release reports, LVAD’s take the workload off a weakened heart by pumping blood through the body.

The press release adds that in developing the HeartMate 3 system, Abbott set a new standard in LVAD therapy—reducing the system’s size while reimagining how blood passes through a heart pump. The HeartMate 3 pump uses technology known as Full MagLev (fully magnetically-levitated) Flow, which reduces trauma to the blood passing through the pump while improving flow.

Nir Uriel (University of Chicago Medicine, Chicago, USA), says: “Approximately a quarter of a million people are living with advanced heart failure, and many of these people will need a heart transplant; however, only a few thousand will receive a new heart. The destination therapy approval for Abbott’s HeartMate 3 device now gives these patients new hope that they can receive a heart pump clinically proven to mitigate challenges we’ve historically confronted with this therapy—stroke and blood clotting—while also offering survival rates on par with transplant.”

Mike Pederson, senior vice president of Abbott’s Cardiac Arrhythmias and Heart Failure business, says: “We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev Technology—takes an established innovation and improves upon it in meaningful ways to help people with advanced heart failure live fuller lives.”

The HeartMate 3 system’s US 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. 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.

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