Abiomed announces FDA approves label expansion for Impella 5.0 and LD
Abiomed announces the U.S. FDA has approved the expansion of the Impella 5.0 and Impella LD PMA labeling for the treatment of cardiogenic shock. The expansion extends the duration of support for each pump from 6 days to 14 days. The Impella 5.0 and the Impella LD are forward flow heart pumps that deliver up to 5 L/min, stabilizing a patient's hemodynamics, unloading the left ventricle, and perfusing the end organs, allowing for the potential of native heart recovery or return to heart function baseline. The Impella 5.0 is implanted through the femoral or axillary artery and the Impella LD is implanted directly into the aorta. "The expanded indication allows for the opportunity to provide longer duration of support for critically ill patients and a longer period of assessment of heart recovery," the company said.