ABIOMED Announces FDA Approvals for BVS-5000 Cardiac Support System.

Business Editors and Health/Medical Writers

DANVERS, Mass.--(BW HealthWire)--March 27, 2001

ABIOMED, Inc. (NASDAQ: ABMD) today announced two regulatory approvals affecting the BVS(R) 5000 Bi-Ventricular Support System ("BVS"), the most widely used advanced cardiac assist system for patients with potentially recoverable life-threatening heart failure.

In one action, the Food and Drug Administration has approved use of ABIOMED's BVS system with the apex of the natural heart's left ventricle as the site of access to blood. The approval allows surgeons the flexibility to support the failing heart by accessing blood via either the left atrium or the left ventricle. ABIOMED requested this approval from the FDA because many surgeons actively using the BVS had indicated a preference for this alternative mode of surgical access.

The FDA also approved ABIOMED's application to begin shipment of BVS product manufactured in the Company's new and enlarged manufacturing facility. The Company expects to phase out its old manufacturing facility by the beginning of this summer.

"Relocation of BVS manufacturing to our newly approved environmentally controlled area is the last step in the consolidation of all of ABIOMED's operations into a new and larger state of the art facility," said Dr. David M. Lederman, President and Chief Executive Officer. "It provides us with improved manufacturing capacity as well as enhanced opportunities for the sharing of operational knowledge, capabilities and experience across product lines."

"While the BVS was the first ventricular assist device to receive marketing approval in the U.S., and from the beginning has captured the majority of the U.S. market for advanced ventricular support of patients with life-threatening but recoverable heart failure, it remains a dynamic product with the potential for continued evolution and improvement", Dr. Lederman said. "ABIOMED is committed to maintaining and growing its industry leadership in heart assistance and replacement. The BVS is, and will continue to be, an important element in our overall corporate growth strategy."

Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced "AB'-EE-O-MED") is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. The Company's AbioCor(TM) implantable replacement heart is in an advanced stage of development and has been granted an Investigational Device Exemption and will soon begin human trials in a select initial patient population. ABIOMED currently manufactures and sells the BVS, a temporary heart assist device, for the support of all patients with failing but potentially recoverable hearts.

This News Release contains forward-looking statements regarding increased manufacturing capacity, improved product flexibility, timing of clinical trials and sustained industry leadership. Investors are cautioned that all such statements involve risks and uncertainties. Readers are cautioned not to place undue reliance on these 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 after the date hereof or to reflect the occurrence of unanticipated events.