FDA approves emergency use of Impella heart pumps to provide unloading therapy for COVID-19 patients

The FDA has issued an emergency use authorization (EUA) for Abiomed’s left-sided Impella heart pumps, approving their use as a tool to provide unloading therapy for COVID-19 patients undergoing extracorporeal membrane oxygenation (ECMO).

“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” Christian Bermudez, MD, a professor of surgery at the University of Pennsylvania in Philadelphia, said in a prepared statement from Abiomed. “The superior clinical outcomes from the combination of Impella and ECMO are likely the result of reducing the stress on the myocardium and work required of the left ventricle, also reducing secondary lung injury due to pulmonary congestion.”

Abiomed refers to that combination of its Impella heart pump and ECMO therapy as ECpella. When COVID-19 causes serious damage to a patient’s lungs and their heart, physicians have found considerable success with ECpella.

In its announcement, Abiomed shared the story of one specific 42-year-old COVID-19 patient who was able to fully recover and return to work thanks to ECpella. That patient’s cardiologist was John Finlay, MD, of Mercy Catholic Medical Center-Fitzgerald Campus in Darby, Pennsylvania. Finlay spoke with Abiomed about the experience.

“It is remarkable to see the patient return home with completely normal heart function, normal respiratory and renal function,” he said. “This case is a testament to the capabilities of ECpella in the setting of severe COVID-19 infection and myocardial involvement. Without our advanced treatment offerings of ECpella, this extremely ill patient would not have survived this COVID-19 infection.”

Earlier this year, Abiomed received a separate EUA for its Impella RP heart pump as a treatment option for COVID-19 patients with right-sided heart failure.