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FDA approves clinical trials of Abiomed’s Impella heart pumps

September 19, 2022


The US Food and Drug Administration (FDA) has granted two approvals related to the clinical research of Abiomed’s Impella heart pumps.

The regulator has approved the on-label RECOVER IV randomised controlled trial (RCT) of Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients.

Abiomed noted that the two-arm study protocol received FDA approval to use the Exception from Informed Consent (EFIC) pathway for subject enrolment.

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