FDA issues emergency use authorization for Impella heart pumps to provide unloading therapy to COVID-19 patients

FDA issues emergency use authorization for Impella heart pumps to provide unloading therapy to COVID-19 patients

Press releases may be edited for formatting or style | August 04, 2020 Cardiology
DANVERS, Mass.--(BUSINESS WIRE)--Aug. 4, 2020-- The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis. Impella is manufactured by Abiomed (NASDAQ: ABMD).

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 is the world’s smallest heart pump. It first received FDA clearance in 2008 and FDA PMA approval as safe and effective in 2015. During the last 10 years, Impella has provided left ventricular unloading to approximately 10,000 ECMO patients in cardiogenic shock. The FDA’s EUA expands the use of Impella as an ECMO unloading therapy to include COVID-19 patients with pulmonary edema or myocarditis.

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

42-year-old Devan Smith, a warehouse worker from Pennsylvania who contracted COVID-19 in May, is an example of a patient who benefited from the unloading effect of Impella. After contracting COVID-19, Devan became severely ill with severe myocarditis, multiorgan failure and respiratory failure. Dr. John Finley, interventional cardiologist at Mercy Catholic Medical Center-Fitzgerald Campus in Darby, Pennsylvania, placed venous arterial (V-A) ECMO to combat the respiratory effects of COVID-19 and placed Impella CP to unload Devan’s heart and allow it to rest and recover. After four days of support, Devan’s heart showed dramatic improvement and he was weaned off Impella. The next morning, he was taken off ECMO support. After three weeks in the hospital, Devan returned home with his native heart functioning normally. In July, he returned to work.

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