Impella: approval for expanded FDA indication for high risk percutaneous coronary intervention (PCI) procedures

The Food and Drug Administration (FDA), the American federal agency responsible for the regulamentation of food and medical products, has expanded FDA indication for the Impella 2.5® and Impella CP® heart pumps during elective and urgent high risk percutaneous coronary intervention (PCI) procedures. Abiomed, Impella producer and consolidated partner of Gada, has announced it on last 14th February.

This expanded approval validates this “first of its kind” indication for high-risk PCI and the benefit of hemodynamic support in treating severely complex patients even without depressed ejection fraction (EF). Impella had previously received FDA approval for PCI, now the ACC / HFSA / SCAI / STS scientific societies guidelines support the use of Abiomed devices in patients with normal or reduced left ventricular function and severe coronary heartery disease requiring complex and prolonged interventions.