AbioCor Implant Performed at Jewish Hospital in Louisville, KY.Business Editors & Health/Medical Writers DANVERS, Mass.--(BUSINESS WIRE)--Jan. 23, 2003 ABIOMED, Inc. (Nasdaq:ABMD ABMD areal bone mineral density ABMD AEGIS Ballistic Missile Defense (US Navy) ABMD Advanced Ballistic Missile Defense ) today reported that an AbioCor(R) Implantable Replacement Heart was implanted yesterday, January 22, by University of Louisville See also
1. ^ [1] 2. ^ [2] URL accessed on June 8 2006 3. surgeons Drs. Laman A. Gray and Robert D. Dowling at Jewish Hospital Jewish Hospital can refer to:
prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. Jewish Hospital, the patient is currently in critical but stable condition. In accordance with ABIOMED's Company policy, and at the request of the patient's family, further details, including the patient's name, will not be released at this time. Based in Danvers, Massachusetts, 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) , a heart assist device for the temporary support of all patients with failing but potentially recoverable hearts. This Release contains references to clinical trials for the AbioCor. Clinical trials are subject to significant risks. ABIOMED's actual results may differ materially from those anticipated for the clinical trials 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. Investors are encouraged to consider these risks and cautioned not to place undue reliance on any forward-looking statements regarding these clinical trials. |
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