DANVERS, Mass. (August 17, 2015) - Abiomed, Inc.(Nasdaq: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.
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.
This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.