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| Abiomed Receives FDA Approval for the Combination iPulse(TM) Circulatory Support System |
Drives Abiomed's IAB, BVS and AB5000 Circulatory Support Systems DANVERS, Mass.--(BUSINESS WIRE)--Dec. 19, 2007--Abiomed, Inc. (NASDAQ: ABMD) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for U.S. commercial distribution of the Company's combination iPulse(TM) Circulatory Support System. The iPulse drives Abiomed and other manufacturer's intra-aortic balloons (IAB), Abiomed's BVS(R) 5000 and AB5000(R) Ventricular Assist Devices (VAD), as well as new products Abiomed may offer in the future. These products are designed to treat patients suffering from acute heart failure by offering various levels of cardiac support, whether minimal, moderate, or full bi-ventricular, to potentially recover the patient's native heart. The iPulse is the first console with the capability to provide either VAD or IAB support in the catheterization lab and surgery suite. "This is an important milestone for Abiomed and an opportune time to be entering the $200 million IAB market," said Michael R. Minogue, Chairman, CEO and President of Abiomed. "We believe the iPulse will create new opportunities in open heart hospitals and help fuel growth in our AB5000 disposables." There are an estimated 160,000 IAB's used globally each year with approximately 110,000 annual U.S. procedures. Over 1,000 open heart hospitals, which include approximately 100 transplant hospitals, could potentially use an IAB today as their initial level of circulatory support in the U.S. Based on Abiomed's internal testing during 510(k) clearance of its IAB, the Company believes its IAB has the fastest inflate-deflate time, and best performance relative to abrasion resistance and triggering. The iPulse should be a more cost-effective system for heart hospitals by supporting procedures with associated Medicare reimbursement that extends across four diagnostic related groups (DRGs) ranging from approximately $20,000 to $215,000 per patient stay. The current installed base of Abiomed's AB5000 Circulatory Support System, prior to the approval of the iPulse, is comprised of approximately 50% of the U.S. transplant hospitals and approximately 20% of the U.S. open heart hospitals. Abiomed's iPulse is also approved in Europe under CE-mark. ABOUT ABIOMED Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. 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 its most recently filed annual report on Form 10-K and quarterly report on Form 10-Q. 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.
CONTACT: Abiomed, Inc. |
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