FDA expands labeling of Impella 5.0 and LD for cardiogenic shock

Abiomed announced 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. Both allow patients to walk around the unit while on support.

Impella heart pumps have FDA PMA approval to treat heart attack patients in cardiogenic shock, and for shock associated with peripartum cardiomyopathy or myocarditis, and have the unique ability to enable the heart to rest and recover, allowing patients to return home with their own heart. 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 FDA’s original PMA approval indicating Impella as safe and effective for the treatment of cardiogenic shock was granted in 2016. This approval was based on an analysis of 415 patients from the FDA study RECOVER 1 and the U.S. Impella registry, and an Impella literature review of 692 patients in 17 clinical studies. Additionally, more than 24,000 Impella patients supported by Impella devices were reviewed in a safety analysis. The Impella heart pump platform is one of the most studied mechanical circulatory support devices and has PMA approvals for high-risk PCI, as a therapy to allow for native heart recovery after cardiogenic shock derived from AMI or cardiomyopathy, and right ventricular heart failure.