Three years ago this week, Abiomed’s (NASDAQ: ABMD) Impella heart pump received its FDA PMA approval for AMI cardiogenic shock.
At the time of Impella’s FDA PMA approval, the cardiogenic shock survival rate to explant in the Impella Quality Assurance (IQ) Database was 51% in the United States1. Today, Impella heart pumps, combined with the adoption of best practices, which include the use of Impella pre-PCI, have contributed to a significant increase in cardiogenic shock survival and native heart recovery. New data from the IQ Database on nearly 5,000 patients treated between April 2018 and March 2019 show an increase in survival from 51% to 67%2, a relative increase of 34% in survival.
Since FDA PMA approval, Abiomed has collected data on nearly 100% of U.S. Impella patients in the observational IQ Database. This clinical data, combined with the FDA post-approval studies embedded in Abiomed’s prospective cVAD Study, helped identify and validate best practices for Impella use associated with improved survival and native heart recovery. These best practices, including use of Impella pre-PCI, reduction of inotropes, early identification of shock, and hemodynamic monitoring with pulmonary artery catheters, have now been validated in multiple publications: Journal of Interventional Cardiology, 2014: Placement of Impella pre-PCI is associated with more complete revascularization and improved survival to discharge in the setting of AMI cardiogenic shock (65% with Impella placed pre-PCI vs. 41% post-PCI, p=0.023).
American Journal of Cardiology, 2017: Initiation of Impella before PCI and prior to initiation of inotropes or vasopressors is independently associated with improved survival. Survival to discharge was 68%, 46%, 35%, 35%, and 26% for patients requiring 0, 1, 2, 3, and 4 inotropes before mechanical circulatory support, respectively
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