Abiomed submits supplements to expand Impella 2.5 FDA pre-market approval


Abiomed has submitted US Food and Drug Administration (FDA) pre-market approval (PMA) supplemental submissions to expand Impella 2.5 PMA approval to the entire Impella family of devices (Impella 2.5, Impella CP and Impella 5.0/LD).

The submissions are for a set of indications related to the use of the Impella devices in patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery. A request for a longer duration of support is also included.

These submissions are proposed as a supplement to the Impella 2.5 PMA approval for high risk percutaneous coronary intervention, and include analysis on 415 patients from the FDA study RECOVER 1 and the US Impella registry, and a relevant Impella literature review that references 692 patients in 17 clinical studies. Additionally, over 24,000 Impella patients supported by Impella devices were reviewed in a safety analysis provided using the FDA/Medical Device Reporting database. Through its review of the supplemental submission, the FDA will ultimately render a decision concerning the safety and efficacy of the Impella CP and the Impella 5.0 in the applied-for patient populations.