ABIOMED Receives FDA Approval for New Cannula.Business/Health and Medical Writers DANVERS, Mass.--(BW HealthWire)--Dec. 30, 1999 -- New Cannula cannula /can·nu·la/ (kan´u-lah) a tube for insertion into a vessel, duct, or cavity; during insertion its lumen is usually occupied by a trocar. can·nu·la or can·u·la n. pl. Provides Additional Flexibility for BVS-5000(R) -- 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 U.S. Food and Drug Administration (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. ) has approved the Company's Pre-Market Approval Application (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) Supplement for an additional arterial cannula, or cardiovascular connector, to be used with ABIOMED's BVS-5000 (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)") bi-ventricular assist device. The BVS is a device that can temporarily take over the full pumping function of the heart. It is used to support patients with potentially reversible heart failure, allowing their failing hearts the opportunity to rest, heal and fully recover. ABIOMED's new cannula is surgically attached to a heart's ascending aorta Noun 1. ascending aorta - the ascending part of the aorta as it emerges from the left ventricle aorta - the large trunk artery that carries blood from the left ventricle of the heart to branch arteries or pulmonary artery pulmonary artery n. Abbr. PA 1. An artery that enters the hilus of the right lung, with branches distributed with the bronchi; right pulmonary artery. 2. by a cardiac surgeon A cardiac surgeon is a surgeon who performs cardiac surgery - operative procedures on the heart and great vessels. Training In the United States and Canada, a cardiac surgery residency typically comprises anywhere from six to nine years (or longer) of training to become during the implantation of the BVS. This new cannula, partially comprised of a Hemashield(R) graft, is smaller in size than prior BVS cannulae and allows proper blood flow to be maintained. "Cardiovascular surgeons continue to seek smaller cannulae that exhibit exceptional handling without compromising the flow characteristics," said Dr. David M. Lederman, President and Chief Executive Officer of ABIOMED. "This new cannula is an important addition to the Company's current product line. Furthermore, this new product demonstrates ABIOMED's ongoing commitment to research and development and furthers our mission of making the BVS the standard of care for cardiac recovery." Dr. Lederman added, "the introduction of this cannula also represents a first and major step forward in ABIOMED's strategic decision to develop and commercialize specialized thin-walled cannulae." About the BVS-5000 The BVS, the most widely-used temporary heart assist device approved by the FDA through the PMA process, is now available in over 435 U.S. Medical Centers including over 80% of all major medical centers that perform more than 500 heart surgeries annually. The BVS is a temporary heart assist device that takes over the pumping function of a patient's failing natural heart allowing it the opportunity to rest, heal and fully recover. It is typically used in one of four patient indications: post-cardiotomy shock, viral myocarditis Myocarditis Definition Myocarditis is an inflammatory disease of the heart muscle (myocardium) that can result from a variety of causes. While most cases are produced by a viral infection, an inflammation of the heart muscle may also be instigated by , failed transplant support or right-ventricular support with a Left Ventricle left ventricle n. The chamber on the left side of the heart that receives the arterial blood from the left atrium and contracts to force it into the aorta. Assist Device (LVAD LVAD left ventricular assist device; see ventricular assist device, under device. ). The BVS is the only temporary cardiac assist device that is approved for the treatment of any patient with potentially reversible heart failure. About ABIOMED Based in Danvers, Massachusetts, ABIOMED, Inc. is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. Based on technology that has been under development for nearly three decades, the Company's AbioCor(TM) Implantable Replacement Heart is in an advanced stage of development and undergoing testing in preparation for initial human trials. ABIOMED currently manufactures and sells the BVS, a temporary heart assist device, for the temporary support of all patients with failing but potentially recoverable hearts. This News Release contains forward-looking statements, including statements regarding development and testing in preparation for initial human trials of the AbioCor(TM) Implantable Replacement Heart and the commercial introduction of a new BVS cannula. Actual results may differ materially based on a number of factors, including unproven markets for new technologies, uncertainties associated with AbioCor development, testing and related regulatory approvals, uncertainty regarding acceptance of new cannulae for the BVS, anticipated future losses, complex and high quality manufacturing requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional funding, dependence on third-party reimbursement and other risks detailed in the Company's filings with the Securities and Exchange Commission. Investors are cautioned that all such statements involve risks and uncertainties. Readers are cautioned not to place undue reliance on 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. ABIOMED(R) and the ABIOMED logo are registered service marks of ABIOMED Inc., AbioCor(TM) , BVS(R) and BVS-5000(R) are registered trademarks of ABIOMED, Inc. Hemashield(R) is a registered trademark of Boston Scientific Corporation. |
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