Abiomed Announces FDA Submission of Impella 2.5, Impella CP & Impella 5.0/LD Pre-Market Approval Supplements

Abiomed, Inc. ABMD, a leading provider of breakthrough heart support technologies, announced today that it has submitted U.S Food & Drug Administration (FDA) pre-market approval (PMA) supplemental submissions requesting to expand Impella® 2.5 PMA approval to all of the 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 (PCI) received on March 23, 2015, and include analysis on 415 patients from the FDA study RECOVER 1 and the U.S. 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 (MDR) 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. Important safety information concerning the Impella CP and the Impella 5.0, including the devices' cleared indications for use, contraindications and warnings, and links to the devices' Instructions for Use manuals can be found at www.abiomed.com/products.