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Stock impact report

Abiomed Receives Approval for Expanded FDA Indication for High Risk Percutaneous Coronary Intervention (PCI) Procedures

ABIOMED, Inc. (ABMD) 
Last abiomed, inc. earnings: 4/30 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: investors.abiomed.com/investor-relations
Company Research Source: GlobeNewswire
DANVERS, Mass., Feb. 14, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced that it has received an expanded U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for the Impella 2.5® and Impella CP® heart pumps during elective and urgent high risk percutaneous coronary intervention (PCI) procedures. This expanded indication confirms Impella support as appropriate in patients with severe coronary artery disease, complex anatomy and extensive comorbidities, with or without depressed ejection fraction (EF). Impella’s initial approval for High Risk PCI was based on two FDA studies (PROTECT I and PROTECT II), that treated the sickest and most severe patients in the catheterization lab with the majority being denied open heart surgery. This change broadens the appropriate use of Impella support and eliminates the requirement for depressed ejection fraction in the presence of severe Show less Read more
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