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ADDING MULTIMEDIA Abiomed Receives FDA Approval of The AbioCor(R), the World's First Completely Self-Contained, Implantable Artificial Heart; AbioCor Granted Humanitarian Device Exemption



    -- Conference Call Scheduled for September 5, 2006 at 3 PM Eastern

    Abiomed, Inc. (NASDAQ: ABMD) announced today it has received
    Humanitarian Device Exemption (HDE) approval from the U.S. Food and
    Drug Administration (FDA) for its AbioCor(R) Implantable Replacement
    Heart (AbioCor). This landmark approval will provide patients
    suffering from heart failure on both sides of their heart
    (bi-ventricular) and who have no other alternative, a viable option
    for extending the quality of their life. The AbioCor is the first
    completely self-contained artificial heart that may allow patients
    more time at home, without wires or tubes piercing through their skin.
    This technology provides patients with complete mobility and remote
    diagnostics.
    According to the American Heart Association's 2006 Statistics,
    each year 57,000 patients in the United States die from chronic heart
    failure. While roughly 2,200 donor hearts are transplanted into
    patients suffering from heart failure, there are many more patients
    awaiting a second chance at life, for whom a heart transplant is not
    an option. Patients with advanced age, organ failure or cancer are, in
    most circumstances, ineligible for a heart transplant and are
    potential candidates to receive the AbioCor implantable heart. The
    Humanitarian Device Exemption (HDE) approval of the AbioCor signifies
    that no comparable alternative therapy exists for patients facing
    imminent death without the technology, and that it has proven to be
    safe and have probable benefit for patients.
    "FDA approval of the AbioCor provides new hope for heart failure
    patients who cannot recover their natural heart or receive a
    transplant. Abiomed has been a leader in recovering patients' hearts
    following an acute event and with this approval, we have expanded our
    product portfolio to treat patients with chronic heart failure as
    well," said Michael R. Minogue, Chairman, CEO and President of
    Abiomed. "We are pleased with this landmark decision and extremely
    proud of the extensive efforts of our employees, scientists, numerous
    healthcare professionals, FDA staff and individuals and families who
    have been actively involved in the clinical study of the AbioCor to
    advance the future of medical technology."
    "This is a momentous day for Abiomed and for all the key
    contributors to the development and advancement of the AbioCor. In
    1964, the National Heart Institute (NHI), now the National Heart, Lung
    and Blood Institute (NHLBI), created its Artificial Heart Program to
    reduce death and disability from heart disease through the development
    of reliable cardiac assist and total replacement heart systems. Today
    marks the realization of that mission, which Abiomed has worked
    towards since the company's founding in 1981," said Robert T.V. Kung,
    Ph.D., Chief Scientific Officer and Senior Vice President of Abiomed.
    Dr. Kung led the evolution of the Abiocor technology over the past 25
    years.
    The AbioCor is intended to replace the severely damaged native
    heart for patients who are not eligible for a transplant and have no
    other treatment alternative. The AbioCor sustains the body's
    circulatory system and is designed to extend the lives of patients who
    would otherwise die of heart failure, while also offering a probable
    benefit for a satisfactory quality of life. A post-market study is
    planned to allow Abiomed to monitor and optimize the introduction of
    the AbioCor into clinical use.
    The FDA decision was completed after extensive review of the
    clinical testing, beginning with clinical trials starting in 2001
    under an Investigational Device Exemption (IDE). The AbioCor would be
    available under an HDE to a limited patient population in the United
    States under this approval, with no more than 4,000 patients receiving
    the technology each year. In order to ensure the highest standards of
    patient care, Abiomed intends to make the AbioCor available through a
    controlled roll-out at approximately five to ten heart hospitals in
    the United States, including qualified clinical trial sites and
    additional qualified centers once they have completed a comprehensive
    and rigorous training program which may take six to eight months.
    Under HDE approval, the FDA may request a panel review of the
    post-approval study data. In addition, Abiomed is working with the
    Centers for Medicare and Medicaid Services (CMS) and private insurers
    to establish reimbursement policies for the AbioCor.
    Jewish Hospital in Louisville, KY, an AbioCor clinical trial site,
    will be among the first U.S. hospitals to offer patients the AbioCor.
    The Jewish Hospital/University of Louisville team, led by surgeons
    Laman Gray, M.D., and Rob Dowling, M.D., performed the first and
    second AbioCor implantable replacement heart procedures in the world
    and a total of seven implants since 2001. Two other hospitals are
    entering into a letter of intent. They are: The Johns Hopkins Hospital
    in Baltimore, MD, with Dr. John Conte, and Robert Wood Johnson
    University Hospital in New Brunswick, NJ, with Dr. Mark Anderson.
    "The AbioCor has the potential to fill a very real void. Patients
    in bi-ventricular heart failure who were not candidates for a heart
    transplant often do not have adequate support with drug therapy or
    even other destination-therapy ventricular assist devices that are
    designed to boost only one side of the heart. Now we can continue to
    treat these severely ill heart failure patients," said Dr. Laman Gray,
    Jr., Professor of Surgery and Director of the Division of Thoracic and
    Cardiovascular Surgery at the University of Louisville School of
    Medicine.

    ABOUT THE ABIOCOR

    The AbioCor(R) Implantable Replacement Heart is one of the most
    sophisticated medical devices ever developed and is designed to extend
    the lives of patients who would otherwise die of heart failure. The
    AbioCor can potentially offer an improved quality of life so that a
    patient can be mobile and continue a productive lifestyle. The AbioCor
    is the only artificial heart without wires piercing through the skin,
    reducing the chance of infection. Its remote diagnostics allow
    patients to return home where they can resume normal activities
    including bathing. The AbioCor is able to pump blood through the body,
    simulating the rhythm of a heartbeat. The complete AbioCor system
    consists internally of a thoracic unit, a rechargeable battery, a
    miniaturized electronics package, a power receiver coil, and
    externally, a power transmitter coil, power and battery pack, handheld
    alarm monitor and sophisticated computer console.
    Abiomed continues to develop next-generation total artificial
    heart technology, the AbioCor II, in order to provide life-saving
    circulatory support to more patients in bi-ventricular heart failure.
    Currently in preclinical evaluation, this technology has the potential
    to last up to five years and is approximately 30 percent smaller than
    the AbioCor.

    CONFERENCE CALL

    A conference call to discuss the HDE approval of the AbioCor will
    occur at 3 PM Eastern Time on September 5, 2006. The conference call
    may be accessed by dialing 800-811-0667 (if dialing from within the
    U.S.) or 913-981-5581 (if dialing from outside the U.S.). Please
    reference Abiomed. A replay of the conference call will be available 3
    hours after the completion of the conference call by dialing
    888-203-1112 (if dialing from within the U.S.) or 719-457-0820 (if
    dialing outside the U.S.). The replay conference ID access code is
    5939154.

    ABOUT ABIOMED

    Based in Danvers, Massachusetts, Abiomed, Inc. is a leading
    developer, manufacturer and marketer of medical products designed to
    assist or replace the pumping function of the failing heart. Abiomed
    currently manufactures and sells the AB5000(TM) Circulatory Support
    System and the BVS(R) 5000 Biventricular Support System for the
    temporary support of all patients with failing but potentially
    recoverable hearts. In Europe, Abiomed offers the IMPELLA(R)
    RECOVER(R) minimally invasive cardiovascular support systems under CE
    Mark approval. The IMPELLA(R) 5.0 and 2.5 are investigational devices
    limited by Federal Law solely to investigational use in the United
    States. Other IMPELLA devices are not yet available for sale in the
    United States. The Company's AbioCor(R) Implantable Replacement Heart
    is now available under a Humanitarian Device Exemption granted by the
    United States Food and Drug Administration. For additional information
    please visit: www.abiomed.com.

    FORWARD-LOOKING STATEMENTS

    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.