May 13, 2019
FDA Approves Extended Duration of Use for Abiomed's Impella Heart Pumps to Treat Cardiogenic Shock
May 13, 2019—Abiomed Inc. announced that the FDA has approved the expansion of the company's Impella 5.0 and Impella LD premarket approval labeling for the treatment of cardiogenic shock from 6 days to 14 days.
According to the company, the Impella 5.0 and the Impella LD are forward flow heart pumps that deliver up to 5 L of blood per minute, stabilizing a patient’s hemodynamics, unloading the left ventricle, and perfusing the end organs to allow for potential 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 devices allow patients to walk around the unit while on support.
Impella heart pumps have FDA approval to treat heart attack patients in cardiogenic shock and for shock associated with peripartum cardiomyopathy or myocarditis. With the expanded indication, critically ill patients have the opportunity for a longer duration of support, and it allows for a longer period of heart recovery assessment, stated the company.
In 2016, the FDA granted the original approval that indicated Impella as safe and effective for the treatment of cardiogenic shock. This approval was based on an analysis of 415 patients from the RECOVER I study and the United States Impella registry, as well as an Impella literature review of 692 patients in 17 clinical studies. Additionally, more than 24,000 patients supported by Impella devices were reviewed in a safety analysis, reported Abiomed.