Abiomed has received a nod from FDA to expand the Impella 5.0 and Impella LD PMA’s labeling for the treatment of cardiogenic shock. The agency has approved the Danvers, MA-based company’s Impella to provide support 10 to 14 days.
Prior to the expansion, the pump was only at six days.
Abiomed’s 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.
In an email, Abiomed told MD+DI “the expanded approval was based on a review of data in Abiomed’s Impella Quality (IQ) Database. The IQ Database contains real-world data on nearly all Impella cases in the U.S.”
Abiomed won PMA approval for Impella as a safe and effective for the treatment of cardiogenic shock in 2016. This approval was based on an analysis of 415 patients from the RECOVER 1 study 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 company gained access to the technology when it acquired Impella CardioSystems AG in 2005.