Abiomed Inc. (ABMD), a provider of breakthrough heart support technologies, announced it has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for a new percutaneous, catheter-based Impella device providing peak flows of approximately four liters of blood per minute.The company stated that 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 designated 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 or IFU, the company said.
In April 2012, Abiomed received CE Marking approval to market the Impella cVAD in the European Union.
Abiomed said it 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.
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