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Abiomed Announces Development of Pediatric Circulatory Support Technology

Posted on: Wednesday, 24 January 2007, 09:01 CST

Abiomed, Inc. (NASDAQ: ABMD) today announced the development of a pediatric circulatory support technology. Currently in pre-clinical studies, Abiomed has developed a catheter-based heart pump, similar to the Impella LP2.5, which provides left-ventricular support to small pediatric patients requiring preconditioning prior to a cardiac intervention, or to recover patients who are either post-surgery, cannot be weaned from bypass, or who have endocarditis. The technology has been designed to operate as either a pulsatile device that can provide up to 120 beats per minute or as a continuous flow technology, and is estimated to provide circulatory support for approximately two weeks.

According to the American Heart Association, approximately one percent of all newborn infants will have some type of structural heart defect. In addition, as with adults, children can experience acute (sudden) heart failure which can be caused by a virus that damages otherwise normal heart muscle or from problems with the coronary arteries, a result from birth or infection. These conditions can prevent effective blood flow to the heart muscle itself. For young patients, recovering the native heart is essential due to the lack of donor organs and also due to the effects of the necessary immunosuppression which can be challenging for these patients.

"There is a clinical need to provide pediatric patients with temporary mechanical circulatory support that can be placed quickly and easily without the need for an extensive surgical procedure. Our current options for this type of support in children are limited," said Elizabeth D. Blume, M.D., Medical Director of the Heart Failure/ Transplant Program at Children's Hospital Boston and Harvard Medical School. "We applaud the efforts of companies like Abiomed to develop smaller pumps capable of supporting our infant and toddler, and school-age patients."

"Abiomed is committed to providing patients-in-need with life-saving circulatory support technologies. The design breakthroughs developed for the Impella LP2.5 in miniaturization and the ability to deliver high blood flows make the device well suited to provide pediatric support. I feel it is our responsibility to help answer the needs of these young patients and their parents," said Michael R. Minogue, Chairman, CEO and President of Abiomed.

Abiomed's Chief Technology Officer, Dr. Thorsten Siess will present information on the new pediatric circulatory support device at the Third International Conference on Pediatric Mechanical Circulatory Support Systems and Pediatric Cardiopulmonary Perfusion being held in Hershey, Pennsylvania, from May 16-19. Dr. Siess' presentation, entitled, "Abiomed's Approach to Pediatric Heart Support with a Catheter-Based Pulsatile 12F Rotary Blood Pump," is scheduled for the session starting at 8 am ET on Saturday, May 19.

The Company plans to pursue CE Mark Approval for this technology in Europe and approval by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE).

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™ Circulatory Support System and the BVS® 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The Company also developed the AbioCor® Implantable Replacement Heart. In Europe, Abiomed offers the minimally invasive Impella® Circulatory Support System under CE Mark approval. The Impella® 5.0 and 2.5 are investigational devices limited by Federal Law solely to investigational use in the United States. Other Impella devices, including the Impella Pediatric Pump, and the iPulse are not yet available for sale in the United States. 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.

Source: Business Wire

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