Abiomed, Inc. (NASDAQ: ABMD), a leading provider of break-through heart support technologies, today announced it has received CE Marking approval in the European Union to market the Impella cVAD device, a new percutaneous Impella ® heart pump that provides peak flow of approximately 4 liters of blood per minute.
The Impella cVAD 1 is designed to provide temporary circulatory support via a minimally invasive, catheter-based pump that is inserted percutaneously, without the need for surgical intervention.
The Impella cVAD further enhances Abiomed’s product portfolio, providing physicians with the clinical flexibility to offer increased flow for patients requiring more hemodynamic support. The increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5.
“We are proud to announce the commercial European availability of the new Impella cVAD device and the growing Abiomed product portfolio,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed.Full commercial availability of the Impella cVAD in the European market is expected by summer 2012. The Impella cVAD is not currently cleared for sale or use in the United States. 1According to the labeling under CE Mark in Europe and other countries, the Impella cVAD (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and cardiac surgery for up to 5 days for the following indications, as well as others: the Impella cVAD is a circulatory support system for patients with reduced left ventricular function, e.g., post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction; the Impella cVAD may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome; support during high risk percutaneous coronary intervention (PCI); post PCI. 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. 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.