ABMD - U.S. FDA gives two approvals to Abiomed Impella heart pumps

• Abiomed ( NASDAQ: ABMD ) said on Friday it had received two approvals from the U.S. Food and Drug Administration related to clinical research of Impella heart pumps for acute myocardial infarction (AMI) cardiogenic shock or heart attack.
• The FDA has approved the on-label RECOVER IV trial for AMI cardiogenic shock patients. RECOVER IV is a trial that is designed to to achieve a Class I guideline recommendation for Impella use in AMI cardiogenic shock.
• The FDA has also approved and closed Impella’s prospective AMI cardiogenic shock post-approval study, dubbed Recover III. This study gathered real-world evidence on AMI cardiogenic shock patients treated with Impella between 2017–2019, collecting detailed data including stages of cardiogenic shock, cardiac output and timing of implantation.

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