On 13 April, Abiomed announced CE mark approval to market its Impella Catheter-Deployed Ventricular Assist Device (cVAD), a new percutaneous Impella heart pump that provides peak flow of approximately four litres 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, without the need for surgical intervention.
“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 CEO, Abiomed.
Full commercial availability of the Impella cVAD in the European market is expected by summer 2012.
This device is not currently cleared for sale or use in the United States.