Last week we reported the news that Abiomed, Inc.’s Impella cVAD™ percutaneously inserted heart pump had been used in a human for the first time. Now a week later the company is announcing that it’s gained CE mark approval.
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 provides physicians with the clinical flexibility to offer increased flow of up to 4 litres of blood per minute 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.
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.
CE mark indications for use
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.
“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.
Source: Abiomed, Business Wire