FDA Expands Impella Pump Indications in High-Risk PCI, Cardiogenic Shock

February 14, 2018

US Food and Drug Administration (FDA)–approved indications for the Impella ventricular assist pumps (Abiomed) have expanded to include high-risk PCI regardless of left ventricular (LV) function, and in cases of cardiogenic shock with causes other than MI or cardiac surgery, the company announced this week. The pumps are percutaneously delivered by catheter for temporary ventricular support.

The Impella 2.5 and Impella CP heart pumps had been approved for temporary ventricular support during urgent or high-risk PCI when ventricular function is depressed. The new indication eliminates the latter restriction, allowing for use regardless of LV function in patients with severe coronary disease, complex anatomy, or extensive comorbidities, according to Abiomed.

In a separate announcement, the company said indications for its Impella 2.5, Impella CP, Impella 5.0, and Impella LD ventricular assist pumps have expanded to include patients with heart failure and cardiogenic shock secondary to cardiomyopathy.

Such cases might include "peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures," Abiomed said.

Previously, the cardiogenic-shock indication for the pumps were limited to shock in the settings of acute MI or heart surgery.

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