Abiomed Receives HDE Supplement Approval For AbioCor(R) Artificial Heart

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices;  Regulatory Affairs / Drug Approvals
Article Date: 24 Jan 2008 - 3:00 PDT

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Abiomed, Inc. (NASDAQ: ABMD) announced that it has received U.S. Food and Drug Administration (FDA) Humanitarian Device Exemption (HDE) supplement approval on system upgrades for its AbioCor® Implantable Replacement Heart (AbioCor). 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 circulation 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. 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.

"This is a momentous day for Abiomed and advanced heart failure patients who cannot recover their natural heart or receive a transplant. We have selected leading U.S. hospitals committed to the AbioCor program and expect patient implants with AbioCor to commence in early 2008," said Michael R. Minogue, Chairman, CEO and President of Abiomed.

Abiomed has selected four sites to date as AbioCor Centers including: The Johns Hopkins Hospital in Baltimore, MD; Robert Wood Johnson University Hospital in New Brunswick, NJ; Texas Heart Institute at St Luke's Episcopal Hospital in Houston, TX; and St. Vincent's Hospital in Indianapolis, IN.

HDE approval allows the AbioCor to be made available to a limited patient population, with no more than 4,000 patients receiving the technology in the United States each year. Abiomed expects to charge $250,000 per AbioCor unit in a controlled roll-out at up to five U.S. centers.

About The Abiocor

The AbioCor®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.

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: http://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, 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 risk factors contained in the Company's Annual Report filed on Form 10-K and recently filed 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.

http://www.abiomed.com