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.
