Abiomed Announces Clinical Progress on Symphony Program, Including Second Successful Implant in CanadaDANVERS, Mass., Oct. 23, 2012 (GLOBE NEWSWIRE) -- Abiomed,Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced clinical updates on its Symphony™ device, including the second successful human use of Symphony in Canada. The procedure was performed by Renzo Cecere, M.D., Director of the Mechanical Assist Program and Surgical Director of the Heart Failure and Heart Transplant Program at the McGill University Health Centre (MUHC) in Montreal, Quebec.
The Symphony device is a minimally invasive implantable heart pump designed to slow the progression of heart failure and help the heart remodel. The first two patient experiences have been positive and informative for the future promise of the therapy. In both patients, an improvement was immediately demonstrated in overall hemodynamics and physical functionality based on support via the subclavian artery through a non sternotomy, "pacemaker-like" implantation technique.
Both patients were implanted at the MUHC by Dr. Renzo Cecere. This newest patient received Symphony in September 2012 and was successfully explanted as planned after 28 days of therapy.
"We were extremely pleased with the patient's overall improvement and the Symphony's performance over 28 days of continuous therapy," said Dr. Cecere. "We look forward to the ongoing development of this program with additional patients in the coming months."
Additionally, Abiomed recently received ANSM (Agence Nationale de Sécurité du Médicament) approval in France, enabling the use of Symphony in clinical trials. Currently, a select number of hospitals in France are training to implant the Symphony device in clinical investigations.
"We are encouraged to learn of the second patient's results with Symphony and believe this unique implantable heart pump will offer a minimally invasive, cost-effective approach to improve hemodynamics for these types of chronic heart failure patients. We look forward to continued clinical progress in Canada and France," said Michael R. Minogue, Chairman, President, and Chief Executive Officer of Abiomed.
The Symphony device is not cleared for sale or use in the United States and is currently being used in clinical investigations in Canada and France.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.
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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 and expected regulatory approvals. 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, including 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 and most recently filed Quarterly Report on 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.
