Abiomed Receives CE Mark for Intra-Aortic Balloon and iPulse Console System.DANVERS, Mass. -- 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 it received the CE Mark for its intra-aortic balloon (IAB (1) See Internet Architecture Board. (2) (Interactive Advertising Bureau, New York, www.iab.net) An industry association founded in 1996 to set standards and guidelines for interactive advertising and marketing. ) and iPulse[TM] console platform. CE Mark approval allows this new combination console and disposable balloon to be sold in all European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community countries as well as many other countries worldwide that accept this approval for registration. Abiomed's IAB is an easy-to-insert, minimally invasive technology designed to enhance blood flow to the heart and other organs for patients with diminished heart function. The iPulse combination console platform drives Abiomed's IAB, 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) 5000 and AB5000 Circulatory Support Systems, as well as new product introductions planned by Abiomed in the future. The iPulse is also designed to be compatible with other Original Equipment Manufacturer's (OEMs) balloons. This technology is intended to provide circulatory support for patients suffering from acute (sudden) cardiovascular failure. In many countries outside the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , the iPulse platform will provide short-term and longer-term support, including bridge to transplant. Abiomed's IAB was recently cleared 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. and culminates more than two years of internal research and development. This 8 French IAB is inserted percutaneously into a patient's descending aorta and inflates and deflates in counterpulsation to a patient's heart rhythm Noun 1. heart rhythm - the rhythm of a beating heart cardiac rhythm regular recurrence, rhythm - recurring at regular intervals atrioventricular nodal rhythm, nodal rhythm - the normal cardiac rhythm when the heart is controlled by the . Abiomed's new IAB was subject to extensive reliability testing and successfully demonstrated a life of over eight million cycles, which equates to more than 90 days of continuous operation. "Receiving CE Mark approval for our intra-aortic balloon pump intra-aortic balloon pump n. A pump connected to a balloon device that is inserted into the descending aorta to provide temporary assistance to the heart in the management of left ventricular failure. system is a significant milestone for Abiomed," said Michael R. Minogue, Chairman, 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. and President of Abiomed. "With this approval we expand our presence in Europe and we will provide patients and physicians with greater access to our extensive portfolio of circulatory support technologies including Impella and the AB5000." Abiomed expects to begin shipping its integrated iPulse console outside the U.S. during fiscal fourth quarter ending March 31, 2007. Abiomed has submitted a pre-market 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 the iPulse to the FDA. Pending regulatory approval in the U.S., Abiomed's initial introduction of the new iPulse to leading U.S. heart hospitals is expected in the summer of 2007. 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. Abiomed currently manufactures and sells the AB5000[TM] Circulatory Support System and the BVS([R]) 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The Company also developed the AbioCor([R]) Implantable Replacement Heart. In Europe, Abiomed offers the minimally invasive Impella([R]) Circulatory Support System under CE Mark approval. The Impella([R]) 5.0 and 2.5 are investigational devices limited by Federal Law solely to investigational use in the United States. Other Impella devices and the iPulse are not yet available for sale in the United States. For additional information please visit: www.abiomed.com. FORWARD-LOOKING STATEMENTS This Release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities. The Company'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 and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. . 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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