FDA Approves Impella Left-Ventricular Heart Pumps for Cardiogenic Shock

The US Food and Drug Administration (FDA) has granted an expanded indication for a line of percutaneous ventricular-assist devices that now allows their use in the treatment of cardiogenic shock patients.

The FDA approved four Impella heart pumps—including the 2.5, CP, 5.0, and LD devices (Abiomed)—for ongoing cardiogenic shock that occurs within 48 hours of MI or open-heart surgery as a result of left ventricular failure unresponsive to medical therapy and conventional treatment. The devices are approved for use in patients with or without an intra-aortic balloon pump.

Meant for short-term use, the Impella 2.5 and CP heart pumps are intended to be used for no more than 4 days whereas the Impella 5.0 and LD are intended to be used for no more than 6 days. The product label, however, allows the heart pumps to be used for longer durations if physicians feel such use is clinically warranted.

The expanded indication for the Impella devices occurred without an FDA advisory panel meeting, although Abiomed did submit data to the FDA for review in support of the expanded indication for cardiogenic shock, including an analysis of 415 patients from the RECOVER 1 study and other data.

The Impella devices have been previously approved to provide circulatory support, with the Impella 2.5 receiving an FDA indication for use in elective and high-risk PCI procedures in 2015. The device first gained market clearance in 2008 on the basis that it was equivalent to currently approved nonroller-type cardiopulmonary bypass pumps.

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