Impella CP heart pump (Abiomed Inc,) receives 510(k) clearance in USA

Abiomed, Inc., announced it has received 510(k) clearance from the FDA for a new percutaneous, catheter-based Impella device providing peak flows of approximately four 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 where a CE Mark was granted in April 2012.