EUA issued for use of heart pumps in patients with COVID-19
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Abiomed announced that the FDA has issued an emergency use authorization allowing its left-sided heart pumps to provide left ventricular unloading and support to certain patients with COVID-19.
The pumps (Impella family of products) are now authorized to be used in patients with COVID-19 who are on extracorporeal membrane oxygenation and develop pulmonary edema or myocarditis, both of which can cause severe LV dysfunction, according to a press release from the company.
“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” Christian Bermudez, MD, surgical director of lung transplantation and ECMO and professor of surgery at the University of Pennsylvania, said in the release. “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.”
As Healio previously reported, the FDA in June granted an EUA to Abiomed allowing use of its Impella RP pump in patients with right ventricular complications caused by COVID-19, including RV dysfunction associated with pulmonary embolism.
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