ABIOMED Receives CE Mark for Impella cVAD

Apr 16 2012

DANVERS, Massachusetts—Abiomed, a provider of heart support technologies, reported that it has received CE mark approval to market the Impella cVAD device, a new percutaneous Impella heart pump that provides peak flow of about 4 liters of blood per minute.  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 device further enhances Abiomed’s product portfolio, providing physicians with the clinical fl exibility to offer increased fl ow for patients requiring more
hemodynamic support. The increased fl ow 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 Minogue, chairman, president/CEO of 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 U.S.

According 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.

Medical Device Daily Daily Staff Report