Abiomed receives FDA clearance for new, higher flow Impella heart pump Abiomed announced it has received 510k clearance from the U.S. 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, or Cardiac Power, within the U.S. and has been commercially known outside the U.S. as the Impella cVAD.
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