Additional Relevant Details The data submitted to the FDA in support of the PMA included an analysis of 415 patients from the RECOVER 1 study and the U.S. Impella registry (cVAD RegistryTM), as well as an Impella literature review including 692 patients from 17 clinical studies. A safety analysis reviewed over 24,000 Impella patients using the FDA medical device reporting (“MDR”) database, which draws from seven years of U.S. Impella experience. The Company believes this is the most comprehensive review ever submitted to the FDA for circulatory support in the cardiogenic shock population.