FDA Approves Abbott’s Heartmate 3 Heart Pump

By MedTech Intelligence Staff

The device is indicated for patients who have advanced heart failure and are not eligible for a transplant.

Certain patients with advanced heart failure may have a chance at a better quality of life with the FDA approval of Abbott’s HeartMate 3 Heart Pump. For patients who are ineligible for a heart transplant, the HeartMate 3 Left Ventricular Assist Device could improve their survival, according to product manufacturer Abbott’s press release.

The LVAD works by easing some of the load placed on a weak heart and assists in pumping blood through the body.

“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 percent at two years. Furthermore, rates of suspected pump thrombosis (clotting of blood) remained very low at 1.1 percent at two years. The study also showcased the lowest-ever published stroke rate (10 percent) for a continuous-flow LVAD at two years.” – Abbott

The product received a CE Mark three years ago and also received FDA approval for “short-term” support in August 2017.

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