Healthcare Industry News: Abiomed
News Release - January 8, 2007
Abiomed Receives CE Mark for Intra-Aortic Balloon and iPulse Console System
DANVERS, Mass.--(HSMN NewsFeed)--Abiomed, Inc. (NASDAQ: ABMD ) today announced it received the CE Mark for its intra-aortic balloon (IAB) and iPulse(TM) console platform. CE Mark approval allows this new combination console and disposable balloon to be sold in all European Union 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 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, the iPulse platform will provide short-term and longer-term support, including bridge to transplant. Abiomed's IAB was recently cleared by the FDA 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. 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 system is a significant milestone for Abiomed," said Michael R. Minogue, Chairman, CEO 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) 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® 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The Company also developed the AbioCor® Implantable Replacement Heart. In Europe, Abiomed offers the minimally invasive Impella® Circulatory Support System under CE Mark approval. The Impella® 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. 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.
Source: Abiomed
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