Healthcare Industry News: intended use
News Release - March 27, 2008
Abiomed Receives European CE Mark Approval for AB5000(R) Portable Circulatory Support DriverEnables Patient Discharge in Europe
DANVERS, Mass.--(HSMN NewsFeed)--Abiomed, Inc. (NASDAQ: ABMD ) today announced it completed the CE Mark for its Portable Circulatory Support Driver. CE Mark approval allows this new Portable Driver to be sold in all European Union countries as well as many other countries worldwide that accept this approval for registration. The Portable Driver is designed to support Abiomedís AB5000TM Ventricular Assist Device (VAD) for both in-hospital and out-of-hospital patients.
The new AB5000 Portable Driver is lightweight, quiet, demonstrates reliable performance, and has the potential to improve patient care while lowering costs to hospitals. The AB5000 Portable Driver provides patients requiring VAD support a greater degree of mobility and improved quality of life during treatment aimed at myocardial recovery. The BVS and AB5000 have exclusive U.S. approvals for all heart recovery indications, and have collectively supported more than 10,000 patients worldwide.
Abiomedís AB5000 Portable Driver, at only 18 pounds, is the lightest and most powerful bi-ventricular system in the industry. It delivers the pressures and vacuums equivalent to Abiomedís AB5000 console and its recently approved iPulseTM combination console. Internal testing of the Portable Driver and the AB5000 Ventricle has demonstrated high reliability. This testing showed that the Portable Driver is capable of providing full support for a yearís intended use. The unit is expected to require low maintenance, approximately every 5,000 hours of operation, which is estimated to be three times longer than existing portable consoles that weigh twice as much or more. Abiomedís Portable Driver was designed with the latest smart battery technology for extended power capability and the quiet operation of the Portable Driver provides for minimal disruption of the patientís quality of life at-home. Abiomed recently announced FDA labeling approval of one year bench reliability for its AB5000 VAD, which is expected to complement the Portable Driver reliability.
ďThere is a clinical and financial demand for a highly reliable mobile driver that allows for patient discharge. We are now offering each heart hospital a complete portfolio of circulatory care products that help the heart recover, from the cath lab to the surgery suite to the I.C.U. to home discharge,Ē said Michael R. Minogue, Chairman, CEO and President of Abiomed.
The AB5000 VAD is approved in Europe under CE-mark and has supported patients for up to 312 days. Outside of the U.S., the AB5000 is used as a bridge-to-recovery (BTR) and bridge-to-transplant (BTT) device, and the Portable Driver is expected to greatly enhance the Companyís BTT market opportunity.
Abiomedís Portable Driver has not been approved by the U.S. Food and Drug Administration (FDA). The Company is pursing an investigational device exemption (IDE) to conduct a discharge study, which was submitted in January 2008 for FDA review. The Company is currently working to resolve open issues and questions from their response. As proposed, the U.S. study would target 20 transplant hospitals for 30 patients.
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.
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 risk factors contained in the Companyís Annual Report filed on Form 10-K and recently filed Form 10-Q. 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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