www.fdanews.com/articles/192856-abiomed-nabs-premarket-approval-for-latest-heart-pump
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Abiomed Nabs Premarket Approval for Latest Heart Pump
September 25, 2019
The FDA granted Abiomed premarket approval for the Impella 5.5 with SmartAssist, its newest heart pump for treating cardiogenic shock.
The minimally invasive device can be used by heart surgeons for up to two weeks in the treatment of cardiogenic shock that occurs less than 48 hours after open heart surgery or acute myocardial infarction.
The temporary pump can deliver flows greater than six liters per minute at its peak and is easier to insert than the previous model. The device eliminates the need for sternotomies or removal of tissue.