Inc, 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(R) 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, 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.
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.