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.
“We are proud to announce the commercial European availability of the new Impella cVAD device and the growing Abiomed product portfolio”
The Impella cVAD 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.
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