Abbott Receives FDA’s Approval for its HeartMate 3 Left Ventricular Assist Device (LVAD) in Patients with Advance Heart Failure

Shots:

• The US approval is based on MOMENTUM 3 trial results enrolling 1000 patients with NYHA Class IIIB or IV heart failure for a short-term endpoint of six months and a long-term endpoint of two years
• The study demonstrated survival rate 82.8% @ 2yrs., clotting of blood 1.1% @ 2yrs., stroke rate of 10 % for a continuous-flow LVAD @ 2 yrs. The approval will support patients not eligible for a transplant can rely on device for rest of life
• The HeartMate 3 LVAD is developed using Abbott’s Full MagLev (fully magnetically-levitated) Flow technology, helps in reducing trauma to the blood passing. In 2015 & 2017, HeartMate 3 system received CE Mark for short-term and long-term support in EU & for short-term support in the US respectively

Click here to read full press release/ article | Ref: Abbott Laboratories | Image: Fortune