The additional FDA indications for the Impella heart pumps continue to roll in.
A day after announcing the FDA’s expanded approval for cardiogenic shock associated with cardiomyopathy, device manufacturer Abiomed said its Impella 2.5 and Impella CP pumps are now indicated for temporary ventricular support during high-risk percutaneous coronary intervention (PCI) regardless of a patient’s ejection fraction (EF).
Previously, the devices—the only of their kind FDA-approved for high-risk PCI—were indicated for use in patients with severely reduced EF. But an analysis of 229 consecutive high-risk patients with mild to moderately reduced EF convinced the FDA the circulatory support systems were useful in these patients as well, according to a press release.
High-risk PCI is considered appropriate for patients with severe coronary artery disease, complex anatomy and extensive comorbidities. Open-heart surgery is often considered too dangerous for these individuals.
“Our patients are increasingly more complex, requiring higher levels of operator skill and protocol-driven use of hemodynamic support in the cath lab," said Tony DeMartini, MD, an interventional cardiologist at Edward-Elmhurst Health in Illinois. "These patients often experience improved quality of life and with complete revascularization can have improved ejection fraction following Protected PCI."