Abiomed Announces Training of Surgical Teams to Prepare for Initial Human Trials of Its Battery-powered Heart.DANVERS, Mass.--(BUSINESS WIRE)--May 5, 1998-- Agreement is reached with the Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world and Brigham and Women's Hospital Brigham and Women's Hospital (BWH) is a hospital in the Longwood Area of the Boston, Massachusetts neighborhood of Mission Hill. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare. ABIOMED, Inc. (pronounced "AB-EE-O-MED"), (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 ) today announced that it has reached agreement with both Massachusetts General Hospital and Brigham and Women's Hospital to begin training surgical teams from both hospitals on ABIOMED's totally implantable heart replacement device in preparation for initial clinical trials. Under the agreements, a project team selected from these two Boston-based medical centers will be trained by ABIOMED in order to demonstrate their readiness for implantation of ABIOMED's heart replacement device in humans. Cardiac surgeons Dr. Gus Vlahakes and Dr. Gregory Couper will lead the medical teams at the Massachusetts General Hospital and Brigham and Women's Hospital, respectively. These two hospitals, acting as a single center, are part of a select group of five U.S. medical centers that will undertake readiness training for initial clinical implantation of the heart replacement device upon approval by the 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. . ABIOMED's totally implantable heart replacement device is in an advanced stage of pre-clinical development Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. . The Company expects clinical trials to begin in the year 2000. The basic technology has been under development since 1977. Elements of this technology are today being used to save human lives as part of ABIOMED's BVS-5000(R), a temporary artificial heart system and the only device approved by the FDA as a bridge-to-recovery device for the treatment of patients with reversibly failing hearts. The replacement heart is designed to take over the full pumping function of the human heart. It is designed for use by patients with irreparably ir·rep·a·ra·ble adj. Impossible to repair, rectify, or amend: irreparable harm; irreparable damages. [Middle English, from Old French, from Latin damaged hearts who are at risk of death from end-stage heart failure End-stage heart failure Severe heart disease that does not respond adequately to medical or surgical treatment. Mentioned in: Heart Transplantation . Commenting on the enrollment of these additional centers, Dr. David M. Lederman, ABIOMED's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. said, "We are delighted that the distinguished medical teams from these two world-renown medical centers have joined our efforts to demonstrate that the human heart can be satisfactorily replaced by a synthetic device that duplicates its function. Our historical scientific interactions with these two Boston Medical Centers Boston Medical Center (BMC) is a non-profit 581-bed medical center in Boston, Massachusetts. It was created by the formal merger of Boston City Hospital (BCH) and Boston University Medical Center Hospital (BUMCH). have resulted in significant advances in cardiac medicine and I am confident that this new effort will eventually result in the saving of thousands of lives that would otherwise be lost to heart disease." 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. develops, manufactures and markets innovative cardiovascular, medical and dental products and is a technology leader in the research and development of advanced artificial heart systems. Located in Boston, the Massachusetts General Hospital and Brigham and Women's Hospital are founding members of Partners HealthCare Partners HealthCare is a non-profit organization that owns several hospitals in Massachusetts, primarily in the Boston area. Massachusetts General Hospital and Brigham and Women's Hospital founded the organization in 1994. System, which is dedicated to excellence in patient care, pioneering research and medical education. Both medical centers have been rated among the top ten hospitals in the country by U.S. News and World Report. This News Release contains forward-looking statements, including statements regarding development of an implantable battery-powered replacement heart and timing of its initial implantation in humans. Actual results, events or performance may differ materially based on a number of factors, including: uncertainty of product development and clinical trials, complex manufacturing, high quality requirements, unproven reliability of products under development, dependence on key personnel, risks associated with growing number of employees, competition and technological change, government regulations including the FDA and other regulatory agencies, reliance on government contracts, dependence on limited sources of supply, future capital needs and uncertainty of additional funding, dependence on third-party reimbursement, potential inadequacy of product liability insurance and dependence on patents and proprietary rights. Investors are cautioned that all such statements involve risks and uncertainties. Readers are cautioned not to place undue reliance on these 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 after the date hereof or to reflect the occurrence of unanticipated events. --30--ls/bos* CONTACT: ABIOMED Investors: John F. Thero or Media: Kristin T. Hurley (978) 777-5410 Ext. 101 |
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