AbioCor Implantable Replacement Heart Procedure Performed At St. Luke's Episcopal Hospital, Home of the Texas Heart Institute.Business/Technology Editors & Health/Medical Writers DANVERS, Mass.--(BUSINESS WIRE)--Sept. 26, 2001 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 ) confirmed today that the Houston-based AbioCor(TM) (pronounced "AB'-EE-O-KOR") clinical and research team, led by Drs. O.H. (Bud) Frazier, performed today the world's third implantation of ABIOMED's AbioCor Implantable Replacement Heart at St. Luke's Episcopal Hospital St. , home of the Texas Heart Institute in Houston, Texas. The procedure conducted today went as expected and the patient is resting comfortably, according to the Hospital. Consistent with the previously announced policy governing the AbioCor clinical trial, additional information will be made available at a later date to be determined by the medical team and the patient's family. This is consistent with the Company's "quiet period" policy intended to protect patient confidentiality patient confidentiality Medical practice A Pt's right to privacy and freedom from public dissemination of information that the Pt regards as being of a personal nature. See HIPAA, Medical privacy. and allow for the best possible medical care. 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 first generation AbioCor Implantable Replacement Heart is being implanted in selected 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 (IDE) 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. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). 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 advice for the temporary support of all patients with failing but potentially recoverable hearts. World-renowned cardiovascular surgeon Denton A. Cooley, MD, founded the Texas Heart Institute in 1962 for the study and treatment of diseases of the heart and blood vessels. Together with the Institute's clinical partner, St. Luke's Episcopal Hospital, it has been ranked among the nation's top ten heart centers in an annual survey published by U.S.News & World Report for the past eleven years. St. Luke's was founded in 1954 by the Episcopal Diocese of Texas The Episcopal Diocese of Texas is one of the largest dioceses of the Episcopal Church in the United States of America. The diocese consists of all ECUSA congregations in the southeastern quartile of Texas, including the cities of Austin, Beaumont, Galveston, Houston (the see city) . St. Luke's is home to the world-renowned Texas Heart Institute, founded in 1962. In 2001, St. Luke's earned the Magnet designation, the highest honor in patient care. It is the first hospital in Texas and the southwest to be so honored. 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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