Results from two studies of the Impella heart pump device will be presented at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando USA and virtual).
This includes the PROTECT III post approval study and the RESTORE EF study. Interim results from both studies were presented at TCT 2020 and demonstrated the benefits of using contemporary practices to achieve complete revascularisation with Impella.
Based on PROTECT II RCT data, and data from additional robust prospective clinical studies, the US Food and Drug Administration (FDA) granted Impella premarket approvals (PMA) as safe and effective for high-risk PCI, cardiogenic shock and right heart failure.
TCT presenters will also review the real-world evidence and best practices gathered since Impella’s FDA approvals. This evidence will inform the RECOVER IV RCT of Impella use in cardiogenic shock patients. The evidence includes prospective data from the National Cardiogenic Shock Initiative (NCSI) Study, J-PVAD Study and INOVA Study. These datasets demonstrate cardiogenic shock best practices, including early use of Impella, are associated with improved survival rates of 71%, 77% and 82% (respectively), compared to the historical cardiogenic shock survival rate of about 50%.
Impella heart pumps are the world’s smallest heart pumps. They unload the heart while providing coronary and end organ perfusion. Impella SmartAssist technology enables improved patient outcomes via real-time intelligence. Abiomed augments limited hospital resources by providing 24×7 support on-site, on-call and online.