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FDA expands premarket approval for Abiomed's heart pumps

Abiomed said its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps were granted expanded premarket approval by the FDA for use in treating heart failure linked to cardiomyopathy leading to cardiogenic shock, in addition to its use for treating acute myocardial infarction cardiogenic shock and postcardiotomy cardiogenic shock. The company also initiated the Women's Initiative, which will concentrate on heart recovery awareness and education.

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