Abiomed Announces Publication of PROTECT II Study in Circulation: Journal of the American Heart AssociationDANVERS, Mass., Sept. 4, 2012 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that results from its PROTECT II study will be published in an upcoming print edition of Circulation, the journal of the American Heart Association. The study, "A Prospective Randomized Clinical Trial of Hemodynamic Support with Impella® 2.5 versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary Intervention: the PROTECT II Study," was accepted for publication on August 20, 2012 and published online on August 30, 2012 via the following link: http://m.circ.ahajournals.org/content/early/2012/08/30/CIRCULATIONAHA.112.098194
The PROTECT II study was a prospective multicenter randomized trial that was "designed to assess whether a high-risk percutaneous revascularization strategy with the support of the Impella 2.5 device would result in better outcomes than a revascularization strategy with intra aortic balloon pump (IABP) support."
"Today marks a very significant milestone in providing new clinical insight for cardiovascular disease patients considered too risky for conventional surgery. The PROTECT II publication in Circulation underscores the importance of this study's observations to the clinical community," said William W. O'Neill, M.D., principal investigator of the PROTECT II trial and medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit.
Study authors include William W. O'Neill, M.D.; Neal S. Kleiman, M.D.; Jeffrey Moses, M.D.; Jose P.S. Henriques, M.D., Ph. D.; Simon Dixon, MBChB; Joseph Massaro, Ph. D.; Igor Palacios, M.D.; Brijeshwar Maini, M.D.; Suresh Mulukutla, M.D.; Vladimir Dzavik, M.D.; Jeffrey Popma, M.D.; Pamela S. Douglas, M.D.; and Magnus Ohman, M.D. Circulation has the highest ranking impact factor among journals in the Cardiac & Cardiovascular Systems category.
"PROTECT II is a landmark clinical trial and we are grateful to Dr. O'Neill and his colleagues for leading this study," said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. "The peer-reviewed publication of PROTECT II in the esteemed Circulation journal is a notable achievement for Abiomed. Most importantly, we believe that this study will advance the treatment for patients with heart failure."
These data in PROTECT II have been collected, validated, and monitored by a third party academic research organization and the major adverse events (MAE) were assessed at 30 and 90 days. Additionally, all hospital charges were tracked by an independent health economic organization in coordination with the study.
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 expected patient outcomes, 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 most recently filed Annual Report 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.
