Abiomed’s Impella RP Heart Pump Gets Labeling Update

The FDA has approved updated labeling of Abiomed’s Impella RP system to better characterize the type of patients who may benefit most from using the heart pump.

The Impella RP is a right heart mechanical circulatory support system that generates forward blood flow in the ascending aorta. The system also includes sensor technology that provides metrics for managing and weaning patients from the pump.

Data from a post-approval study supported an updated indication for patients “without the presence of profound shock, end organ failure or acute neurologic injury,” the agency said, calling for this addition to the approved labeling.

The updated indication is for providing temporary right ventricular support for up to 14 days in patients who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant or open‐heart surgery.