Impella CP Offers High Flow Percutaneous Heart Pump
The Impella CP (Cardiac Power) is a percutaneous, catheter-based Impella ventricular assist device (VAD) providing peak flows of approximately 4 liters of blood per minute. The increased flow is delivered on the same console platform, 9 French catheter and introducer as the Impella 2.5. This new heart pump will be marketed as the Impella CP (Cardiac Power) within the United States and has been commercially known outside the U.S. as the Impella cVAD.
This 510(k) clearance designates that the Impella CP has the same indications for use as the Impella 2.5 and includes a limitation in the Impella CP instructions for use (IFU). In April 2012, Abiomed received CE marking approval to market the Impella cVAD in the European Union. Abiomed plans to have a controlled launch with top heart hospitals in the United States, with full U.S. commercial availability of the Impella CP expected by the fourth quarter of fiscal 2013.
Abiomed has three FDA studies (PROTECT I, RECOVER I, PROTECT II) that are now published on Impella, and there are also over 150 peer reviewed publications including real world usage data from the Europe and U.S. Impella registries. Additionally, Impella has been utilized to support over 10,000 U.S. patients, has been incorporated into the medical guidelines and has recently been approved for a dedicated CPT code for physician payment.
The U.S. Food and Drug Administration (FDA) cleared the device in September 2012.
For more information: www.abiomed.com