Abiomed Announces Update on 510(k) Clearance Process for Impella 2.5 Circulatory Support Device; Estimated FDA Review Date for Bench Testing Results Extended

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD) today announced an update on the 510(k) clearance process related to its Impella® 2.5 circulatory support device. While there are no guarantees, the Company remains confident that the Impella 2.5 device is on the substantially equivalent (SE) path based on informal feedback from the U.S. Food and Drug Administration (FDA). Abiomed is currently in an interactive review with the FDA on bench testing results of the Impella 2.5, the remaining area of concern. The Company does not anticipate additional bench testing studies at this time, but remains prepared to answer any questions from the FDA during the ongoing discussions. Abiomed believes that the review of the bench testing results will not be completed by the FDA before March 31, 2008, as originally estimated by the Company in November 2006. This estimate was a Company forecast and not an FDA timeline or deadline. Abiomed now estimates that the review of the bench testing results by the FDA will be completed some time during the quarter ending June 30, 2008.