ABIOMED Gains FDA Approval for its New AB5000 Circulatory Support System Console.Business Editors/Health/Medical Writers DANVERS, Mass.--(BUSINESS WIRE)--May 1, 2003 ABIOMED, Inc. (Nasdaq:ABMD ABMD areal bone mineral density ABMD AEGIS Ballistic Missile Defense (US Navy) ABMD Advanced Ballistic Missile Defense ) announced today that it has received 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. approval for commercial distribution of the Company's new AB5000(TM) Circulatory Support System drive and control console. The AB5000 Console will be on display for the first time at the Annual Meeting of the American Association American Association refers to one of the following professional baseball leagues:
AATS Ames Airborne Tracking Sunphotometer AATS Alternate Aircraft Takeoff System AATS Anti Aircraft Target System AATS Aircrew/Aircraft Tasking System AATS Audit Action Tracking System ) being held May 4, 5, and 6 in Boston, Massachusetts “Boston” redirects here. For other uses, see Boston (disambiguation). Boston is the capital and most populous city of Massachusetts.[3] The largest city in New England, Boston is considered the unofficial economic and cultural center of the entire New . The AB5000 console will drive one or two 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) 5000 blood pumps, either in the hospital or for transport of patients between hospitals. Incorporating a state-of-the-art electronic interface, the AB5000 is designed to improve the convenience and ease-of-use of the current BVS blood pump. "The AB5000 Circulatory Support System Console The system console, root console or simply console is the text entry and display device for system administration messages, particularly those from the BIOS or boot loader, the kernel, from the init system and from the system logger. is the cornerstone of ABIOMED's commitment to provide the highest quality technology to serve a broad spectrum of the circulatory support needs of critically ill patients," said Gene Rabe, ABIOMED's Senior Vice President for Sales and Services. "Our hospital customers and their patients will see immediate benefits in terms of improved convenience and ease-of-use of our current BVS blood pump. The AB5000 is also a state-of-the-art technology platform that will support a series of new heart assist disposable products currently under development at ABIOMED. We anticipate a very positive customer reception for this initiative, which is responsive to what our best and most frequent users have been telling us they want and need." The first of ABIOMED's planned new single-use blood pumps is intended to provide improved quality of life and mobility for post-cardiotomy and other short-term bridge-to-recovery patients, and is currently under review at the FDA. 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. ABIOMED currently manufactures and sells the BVS, a heart assist device for the temporary support of all patients with failing but potentially recoverable hearts. The Company's AbioCor Implantable Replacement Heart is the subject of an initial clinical trial being 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. This Release contains forward-looking statements, including statements regarding future product development activities. 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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