Abiomed, Inc. (NASDAQ:ABMD), ein führender Anbieter bahnbrechender Herzunterstützungstechnologien, gab heute bekannt, dass er für die Herzpumpen Impella 2.5(TM), Impella CP®, Impella 5.0(TM) und Impella LD(TM) von der U.S. Food and Drug Administration (FDA) die Zulassung vor dem Inverkehrbringen (PMA) zur Behandlung kardiogener Schocks erhalten hat. In diesem Kontext stabilisieren die Herzpumpen von Impella die Hämodynamik des Patienten, entlasten den linken Ventrikel, sorgen für ein Durchströmen der Endorgane und ermöglichen die Wiederherstellung der normalen Herzfunktion. Diese neue Genehmigung ergänzt die vorherige FDA-Indikation für Impella 2.5 bei hochriskanten perkutanen Koronarinterventionen (PCI) oder Protected PCI(TM) vom März 2015.
Mit dieser Genehmigung sind
Mit dieser Genehmigung sind
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