ABIOMED Receives FDA Permission to Continue AbioCor Clinical Trial.

Business Editors and Health/Medical Writers

DANVERS, Mass.--(BW HealthWire)--Nov. 26, 2001

ABIOMED, Inc. (NASDAQ:ABMD) announced today that it has received permission from the U. S. Food and Drug Administration to move forward, without interruption, to enroll an additional five (5) patients in the initial U.S. clinical trial of the AbioCor(TM) Implantable Replacement Heart. Under the terms of the Investigational Device Exemption, the initial AbioCor trial consists of a total of fifteen (15) patients divided into three groups of five (5) each.

"We are very pleased that the FDA has given us the green light to continue with the AbioCor clinical trial without delay," said Dr. David M. Lederman, ABIOMED's Chief Executive Officer. "The extremely promising clinical results observed to date with our first five patients is a reflection of the extraordinary work done by both the Company's AbioCor team members and the medical teams at each of our participating clinical trial sites. The first five AbioCor patients have demonstrated that we have made significant progress toward the ultimate goal of providing meaningful life extension to end-stage heart failure patients with no other alternative. But there is much left to prove and many lessons to be learned as we proceed. We look forward to these next implants with great hope and high expectations."

The initial clinical trial of the AbioCor Implantable Replacement Heart is intended to prove that the AbioCor is both effective and safe for patients who otherwise have less than 30 days to live and no other therapeutic alternative. The success of the AbioCor will be measured both by how well it extends life and by the degree to which it is able to restore a good quality of live for these patients.

The AbioCor clinical trial began on July 2, 2001 when Mr. Robert Tools received the first AbioCor implant at Jewish Hospital in Louisville, Kentucky. Subsequent implants were performed at Jewish Hospital on September 13, at the Texas Heart Institute, Houston, Texas on September 26, at UCLA Medical Center, Los Angeles, California on October 17, and at Hahnemann University Hospital, Philadelphia, Pennsylvania on November 5. The five patients are in varying stages of rehabilitation and the clinical teams report that the AbioCor hearts have functioned flawlessly in each case.

In starting evaluation of the AbioCor with patients who are very near death, suffering from poor quality of live and without therapeutic alternatives, the Company hopes to demonstrate that the AbioCor is an effective treatment option for the rehabilitation of such very sick patients. As a consequence of their sick hearts, these patients exhibit pre-operative failure of other vital organs causing the rehabilitation process to be long and sometimes complicated despite good circulatory support from the AbioCor heart. As the technology is proven effective it is the Company's plan to work on making future generations of the technology reliable for increasing durations of time and gradually for use in less sick patients. While it is ABIOMED's goal to eventually achieve five-year operational reliability, and the Company believes that goal is attainable, the Company cautions that its ongoing reliability growth program has not yet achieved milestones to demonstrate that the AbioCor can support the lives of recipients for multiple years.

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 Implantable Replacement Heart is being implanted in patients as part of an initial clinical trial conducted under an Investigational Device Exemption from the United States Food and Drug Administration. The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. ABIOMED currently manufactures and sells the BVS(R), a heart assist device for the temporary support of all patients with failing but potentially recoverable hearts.

This Release contains forward-looking statements, including statements regarding the anticipated timing and results of clinical trials for the AbioCor. ABIOMED'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, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing and other risks detailed in the Company's filings with the Securities and Exchange Commission. 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.