Hemolung RAS and ECCO2R have also been assessed to treat moderate to severe acute respiratory distress syndrome in the UK REST study
ALung Technologies has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Hemolung respiratory assist system (RAS) to treat patients with COVID-19.
At present, the Hemolung RAS is being used in the FDA-approved VENT-AVOID study to evaluate low-flow extracorporeal carbon dioxide removal (ECCO2R) in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AE-COPD).
Hemolung RAS and ECCO2R have also been evaluated to treat moderate to severe acute respiratory distress syndrome (ARDS) in the concluded UK REST study that recruited 412 patients.
According to the company, the Hemolung RAS is not FDA-cleared or approved and is not having FDA-approved or cleared device treatments for lung failure resulted due to the COVID-19.
The FDA assessed in vitro and in vivo information in support of ALung’s ongoing US VENT-AVOID clinical trial for Hemolung RAS
The company submitted and the FDA evaluated in vitro and in vivo information in support of the company’s ongoing US VENT-AVOID clinical trial for the Hemolung RAS and additional information regarding the clinical use of the Hemolung RAS outside the US.
Additional biocompatibility, cytotoxicity, and performance testing were also conducted with the Hemolung respiratory assist system.
The FDA stated that it considers the Hemolung RAS has the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation, to minimise hypercapnia and hypercapnic acidosis due to COVID-19.
It is also expected to maintain normalised levels of the partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19.
ALung Technologies chairman and CEO Peter DeComo said: “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.
“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).”
In April 2017, ALung secured $36m of funding to advance the development of its Hemolung RAS system.