ABIOMED Announces Japanese Approval for BVS Heart Assist System.Business Editors and Health/Medical Writers DANVERS, Mass.--(BUSINESS WIRE)--Oct. 23, 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 ) today announced that the Japanese Ministry of Health, Labor and Welfare has granted approval for its distributor, MEDIX MEDIX Medical Engineers and Doctors Intelligence Exchange JAPAN, Inc., to market and sell 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) biventricular heart support system in Japan. "We are extremely pleased by this important milestone, which will allow us to bring our proven BVS system, the most widely used advanced heart assist technology in the world, into one of the world's largest medical device markets," said ABIOMED Sr. VP for Sales and Marketing, Mr. Gene Rabe. "Japanese marketing approval reflects the results of a multi-year effort by ABIOMED in partnership with MEDIX JAPAN, Inc. We look forward to working further with them to secure appropriate reimbursement for our technology, and to build a network of clinical centers using the BVS to save human lives in Japan." The BVS provides short-term assistance to one or both sides of the heart, or can completely take over the heart's pumping function, often allowing the damaged or stunned stun tr.v. stunned, stun·ning, stuns 1. To daze or render senseless, by or as if by a blow. 2. To overwhelm or daze with a loud noise. 3. heart to rest and recover. 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(TM) 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, a heart assist device for the temporary support of all patients with failing but potentially recoverable hearts. This Release contains forward-looking statements regarding reimbursement and sales of the BVS in Japan. 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 regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, 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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