FDA issues EUA for left-sided Impella to provide left ventricular unloading

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Impella CP

The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and develop pulmonary edema or myocarditis. Impella is manufactured by Abiomed.

COVID-19 causes widespread inflammation which can result in damage to the lungs and heart. This damage may cause severe left ventricular dysfunction manifesting as pulmonary edema and/or myocarditis. Impella combined with ECMO therapy (known as ECpella) has become an important tool for physicians treating COVID-19 patients suffering from both heart and lung failure.

Impella received FDA clearance in 2008 and FDA PMA approval as safe and effective in 2015

“The early clinical evidence continues to accrue in favour of including left ventricular unloading in many patients on ECMO,” said Christian Bermudez, surgical director, lung transplantation and ECMO, and professor of surgery at the University of Pennsylvania, Philadelphia, USA. “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.”

This is the second EUA the FDA has granted for Impella during the COVID-19 pandemic. On May 29, 2020, the FDA issued an EUA to expand the use of Impella RP to include patients suffering from COVID-19-related right ventricular complications, including right ventricular dysfunction associated with pulmonary embolism.


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