Abiomed has received CE Mark 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 cVAD1 is designed to provide temporary circulatory support via a minimally invasive, catheter-based pump that is inserted percutaneously, according to the Danvers, Mass.-based company. The Impella cVAD updates Abiomed's product portfolio, providing 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.
Abiomed expects commercial availability of the Impella cVAD in the European market by this summer. The Impella cVAD is not currently cleared for sale or use in the U.S.