FDA approves updated heart pump
Published date : 11 September 2012
Article date : 11 September 2012
Cardiovasclar Business reports that the FDA has granted Abiomed clearance on a percutaneous, catheter-based Impella device providing peak flows of approximately four liters of blood per minute.
They say that the increased flow is delivered on the same console platform '9 French' catheter and introduced as the Impella 2.5. The 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.
The FDA 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.
Apparently, the device is 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 plans a controlled launch with leading heart hospitals in the U.S., with full U.S. commercial availability of the Impella CP expected towards the end of 2013.
Source: Cardiovascular Business, 10 September 2012
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