DANVERS, Mass.--(BUSINESS WIRE)--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 (p <0.001), in an analysis of 281 AMI cardiogenic shock patients.
Journal of Interventional Cardiology, 2017: Demonstrates a 48% survival at 30 days when Impella is implanted pre-PCI, compared to a 13% survival when Impella is implanted post-PCI for left main in cardiogenic shock (p=0.004).
American Heart Journal, 2018: Analysis of 15,259 U.S. patients in the IQ Database demonstrated an improvement in survival to explant from 52% to 59% when Impella was placed pre-PCI (p=0.001).
National Cardiogenic Shock Initiative Study Late Breaking Clinical Science, TCT 2018: Data from the first 104 patients utilizing best practices in the National Cardiogenic Shock Initiative (NCSI) Study found 77% survival to discharge with 99% native heart recovery.

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