The EUA covers the left-sided Impella pumps in providing left ventricular unloading, supporting COVID-19 patients who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and develop pulmonary edema or myocarditis, according to a news release.
Impella, the world’s smallest heart pump, combined with ECMO therapy (Abiomed’s therapy is called ECpella) helps to treat COVID-19 patients suffering from both heart and lung failure due to the virus’ capabilities of causing widespread inflammation that damages the heart and lungs.
“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” University of Pennsylvania professor of surgery & surgical director of lung transplantation & ECMO Dr. Christian Bermudez 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.”
Danvers, Mass.-based Abiomed already received one EUA for its Impella platform, as the FDA authorized the Impella RP for use with COVID-19-related right heart failure in May. The combination of the two EUAs gives the option to use the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and the Impella RP for use with COVID-19 patients.
The company cited the example Pennsylvania warehouse worker Devan Smith (42), who contracted the virus in May and became severely ill with myocarditis, multiorgan failure and respiratory failure. Smith received treatment with the Impella CP, along with venous arterial ECMO, and after four days of support, he was weaned off the Impella and ECMO support and left the hospital with his native heart functioning normally after three weeks.
“I’m so thankful for the physicians, nurses and staff who saved my life,” Smith said. “My recovery was made possible by their use of life-saving therapies, like Impella and ECMO, that allowed my body to overcome COVID-19.”