Additional requests filed with FDA for Impella family of heart pumps in cardiac surgery patients- Abiomed

Abiomed has submitted an FDA pre-market approval supplemental submissions request to expand its Impella 2.5 PMA approval to all of the Impella family of devices, which includes the Impella 2.5, Impella CP and Impella 5.0/LD. The submissions cover a set of indications in patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery. A request for a longer duration of support is also included.

These requests are proposed as a supplement to the latest Impella 2.5 PMA request – in this case for patients with high risk percutaneous coronary intervention, which was placed in March 2015, and includes analysis on 415 patients from the RECOVER 1 study and the US Impella registry, as well as an Impella literature review referencing 692 patients in 17 clinical studies. Finally, over 24,000 patients supported by Impella devices were reviewed in a safety analysis provided using the FDA/Medical Device Reporting database.