ALung Technologies announced today that it received FDA emergency use authorization (EUA) for its Hemolung respiratory assist system (RAS) for treating COVID-19.
Pittsburgh-based ALung said in a news release that it already treated numerous COVID-19 patients in the U.S. under existing FDA emergency use provisions, as well as in Europe, where it’s had CE Mark approval since 2013.
The Hemolung system is designed to use ECCO₂R therapy to allow carbon dioxide to be removed from the blood independently of the lungs in an effort to facilitate the avoidance or reduction of intubation and invasive mechanical ventilation, according to ALung’s website.
Hemolung is currently being used in the FDA-approved Vent-Avoid trial for studying ECCO2R for acute exacerbation of chronic obstructive pulmonary disease (AE-COPD). A United Kingdom trial with 412 patients that used Hemolung for acute respiratory distress syndrome (ARDS) recently concluded as well.
The FDA reviewed in vitro and in vivo information in support of ALung’s ongoing trial for Hemolung, along with clinical info from outside the U.S., to conclude that the system has the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation to reduce hypercapnia and hypercapnic acidosis due to COVID-19.
Hemolung could also maintain levels of partial pressure of carbon dioxide and pH in patients suffering from acute, reversible respiratory failure due to COVID-19, according to a news release.
“We are pleased with the FDA’s recognition that the Hemolung may be beneficial in the treatment of COVID-19 by removal of CO2 directly from the blood during extracorporeal therapy,” ALung chairman & CEO Peter DeComo said in the release. “With published mortality rates as high as 90% for patients receiving invasive mechanical ventilation (IMV), we believe that the Hemolung can be a valuable tool for physicians to be used in conjunction with IMV, by reducing or eliminating the potential of further lung damage caused by high ventilator driving pressures, often referred to as ventilator-induced lung Injury (VILI).”