Abiomed Seeks Expanded Indications for Impella Line

August 17, 2015—Abiomed, Inc. announced that it has made US Food and Drug Administration (FDA) premarket approval (PMA) supplemental submissions requesting to expand PMA approval of its Impella 2.5 device 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 experiencing cardiogenic shock after acute myocardial infarction or cardiac surgery. The company’s request also includes an indication for a longer duration of support.

Abiomed stated that these submissions are proposed as a supplement to the Impella 2.5 PMA approval for high-risk percutaneous coronary intervention received on March 23, 2015, and include analysis of 415 patients from the FDA study (RECOVER I) and the United States Impella registry, as well as a relevant literature review that references 692 patients in 17 clinical studies. Additionally, the company used the FDA/Medical Device Reporting database to provide a safety analysis reviewing more than 24,000 patients treated using Impella devices.

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 devices in the applied-for patient populations, advised Abiomed.