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

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

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  • 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

Ref: Abbott Laboratories | Image:  Abbott

Click here to­ read the full press release 

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