FDA approves updated Impella

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The FDA has granted Abiomed 510(k) clearance for its 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 introduced as the Impella 2.5, according to the Danvers, Mass.-based company. This heart pump will be marketed as the Impella CP (Cardiac Power) within the U.S. and is known commercially 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 (i.e., "intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to six hours. It is also intended to be used to provide partial circulatory support (for periods up to six hours) during procedures not requiring cardiopulmonary bypass").

But, this approval includes a limitation in the Impella CP instructions for use. Specifically, the device "intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to six hours. It is also intended to be used to provide partial circulatory support (for periods up to six hours) during procedures not requiring cardiopulmonary bypass."

Abiomed said it plans to have a controlled launch with "top heart hospitals" in the U.S., with full U.S. commercial availability of the Impella CP expected by the fourth quarter of fiscal 2013. Also, Impella has recently been approved for a dedicated CPT code for physician payment, the company reported.

In April 2012, Abiomed received CE Mark approval to market the Impella cVAD in the European Union.