AbioCor Patient Achieves One-Year Milestone Today.Business Editors & Health/Medical Writers DANVERS, Mass.--(BUSINESS WIRE)--Sept. 13, 2002 ABIOMED, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ABMD ABMD areal bone mineral density ABMD AEGIS Ballistic Missile Defense (US Navy) ABMD Advanced Ballistic Missile Defense ) is very pleased to report that Mr. Tom Christerson, the second recipient of the AbioCor(TM) Implantable Replacement Heart, has today reached one year. Mr. Christerson is the first AbioCor clinical trial patient, and the first replacement heart patient ever, to be discharged home (April 16, 2002). He is also the longest living patient on the battery-powered heart. Prior to receiving the AbioCor at Jewish Hospital Jewish Hospital can refer to:
1. The age until which a person is expected to live. 2. The remaining number of years an individual is expected to live, based on IRS issued life expectancy tables. of thirty days or less and was not eligible for heart transplantation Heart Transplantation Definition Heart transplantation, also called cardiac transplantation, is the replacement of a patient's diseased or injured heart with a healthy donor heart. . "We could not be happier for Tom and the rest of the Christerson family," said Dr. David M. Lederman, ABIOMED's Chief Executive Officer. "Tom is proof that the AbioCor works and that a patient living on the AbioCor, who was before on the brink of death because of heart disease, can be restored to a life of good quality. A year ago Tom could barely take a step; tomorrow he and his family are planning to champion a community Heart Walk. Achieving this anniversary milestone shows that the lives of such patients can be extended and improved." Based in Danvers, Massachusetts Danvers is a town in Essex County, Massachusetts, United States. Located on the Danvers River near the northeastern coast of Massachusetts, Danvers is most widely known for its association with the 1692 Salem witch trials. , 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. The Company's AbioCor Implantable Replacement Heart is being implanted in patients as part of an initial clinical trial conducted under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. ABIOMED currently manufactures and sells the BVS BVS Biblioteca Virtual em Saúde (Brazil) BVS Bureau of Vital Statistics BVS Brethren Volunteer Service (Church of the Brethren) BVS Boston Vegetarian Society (Cambridge, MA) (R), a heart assist device for the temporary support of all patients with failing but potentially recoverable hearts. This Release contains forward-looking statements, including statements regarding the anticipated results of clinical trials for the AbioCor. ABIOMED'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 detailed in the Company's filings with the Securities and Exchange Commission. 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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