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FDA Expands Approval for Impella Heart Pumps

from Cardiovascular Business

The Food and Drug Administration has expanded its premarket approval for Impella heart pumps to include treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock, device manufacturer Abiomed announced Feb. 13. The Impella pumps, which provide circulatory support, were previously approved in April 2016 to treat patients in acute myocardial infarction cardiogenic shock and post-cardiotomy cardiogenic shock. more

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