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Press Contact:
Liza Heapes
Ph: 978-646-1668
Email: lheapes@abiomed.com

 
70 percent of Survivors Recover Heart Function

DANVERS, Mass. (January 25, 2005) – ABIOMED, Inc. (NASDAQ: ABMD) a manufacturer of products for circulatory care and support, today provided a clinical update for the AB5000 Circulatory Support System. Formally launched in April 2004, outcomes have continued to improve as the system has gone into wider use. ABIOMED's ventricular assist devices, the AB5000 and the BVS® 5000, are the only devices approved for Bridge-to-Recovery treatment following AMI-cardiogenic shock (shock following a heart attack). The systems are also used to support the heart and allow for potential recovery following other acute events including post cardiotomy cardiogenic shock (shock following coronary bypass surgery), and viral myocarditis, a virus that attacks the heart.

Key facts on AB5000 usage and outcomes, based on ABIOMED's voluntary data registry:

  • More than seventy percent of survivors have been able to go home with their own hearts. In addition, recovery of kidney function has allowed some heart patients to avoid planned kidney transplants.
  • One in four patients have been transitioned from the BVS 5000 to the AB5000. This transition took place without re-opening the chest, avoiding bleeding and other risks associated with additional surgery to change out to other devices.
  • Mean duration of support on the AB5000 is three times longer than on the BVS5000, with many patients requiring support beyond 30 or 60 days and some beyond 90 days. In bench testing, the AB5000 Ventricle has operated nearly a year and is continuing.
  • While patients are implanted with the AB5000 with the goal of recovering the heart, there have been some instances in which, after giving a patient's heart a full opportunity to recover, doctors have determined that recovery will not occur. Nearly thirty percent of survivors have received heart transplants after it was determined that native heart function would not return; their average duration of support on the AB5000 was nearly 40 days.
  • 20 percent of all AB5000 patients were supported following AMI-Cardiogenic shock.
  • 47 percent of all AB5000 patients required support on both sides of the heart.
  • Nineteen patients have ambulated while on AB5000 support, walking hospital grounds as well as using treadmills and stationary bicycles.

"I am very encouraged by our results with the AB5000. This device provides adequate time, sometimes several weeks or more, for the patient's own heart to recover from an acute cardiac event," said Jack Crumbley, Director of Cardiac Transplantation at the Medical University of South Carolina. "The AB5000 allows full ambulation and active physical therapy, while minimizing adverse events. Because all the ABIOMED cannulae are compatible, patients rescued with the BVS can be easily transitioned to the AB without additional surgery. Also, the longer support time makes the AB5000 suitable for the consideration of other options if the patient's own heart does not recover."

ABIOMED's approved products, the BVS 5000 and AB5000, are indicated for Bridge to Recovery. Independent studies have indicated that the potential US caseload for Bridge to Recovery patients is 60,000 patients per year. Currently less than 1,000 patients per year actually receive temporary support from a ventricular assist device with the goal of recovery, even though the alternative is usually death.

"Our focus is recovering the heart, which is the best option both for patients and the hospital," commented Michael R. Minogue, CEO and President of ABIOMED. "We are committed to providing not only technology leadership, but also the clinical education and support necessary to help save lives."

About ABIOMED
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. ABIOMED, which currently sells the BVS® 5000 Biventricular Support System and the AB5000™ Circulatory Support System, is the market leader in devices for the temporary support of patients with failing but potentially recoverable hearts. In September 2004, ABIOMED applied for initial FDA market approval for the AbioCor Implantable Replacement Heart to treat a defined subset of irreversible end-stage heart failure patients under a Humanitarian Device Exemption.

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. 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, 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 and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed 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.

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Media Contact:
Andrea tenBroek
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com

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Jane Petrino
Noonan/ Russo
(212) 845-4274
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