Coronavirus News: FDA Gives Emergency-Use Authorization To Heart Pump For COVID-19 Patients

Abiomed (ABMD) said it has received emergency-use authorization from the U.S. Food and Drug Administration (FDA) for its left-sided Impella heart pumps to support COVID-19 patients.

The pumps are used for extracorporeal membrane oxygenation (ECMO) treatment of pulmonary edema or myocarditis often caused by COVID-19.

Because COVID-19 can cause lungs and heart damage, some patients develop severe left ventricular dysfunction. That can manifest as edema or myocarditis, which requires the use of ECMO therapy to treat their heart and lung failure.

Abiomed received FDA premarket approval of the Impella in 2015, which has now been expanded to emergency use authorization of the heart pump to treat COVID-19 patients. This is the second emergency use authorization of the pump by the FDA during the pandemic for Abiomed. The pump was previously used to treat patients that suffered from right ventricular complications from COVID-19.

“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” Christian Bermudez, MD, surgical director at ECMO and professor of surgery at the University of Pennsylvania said in a statement.

“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,” he added.

Shares of Abiomed were trading at $306.86 as of 10:59 a.m. ET, down $1.49 or 0.48%.