The Hemolung Respiratory Assist System (RAS) received European marketing clearance (CE Mark) in 2013 as the world’s first fully integrated Respiratory Dialysis ® system. The simplicity, safety and effectiveness of the system have been demonstrated in use at more than 100 hospitals worldwide. The device is approved in 34 countries outside of the US, including Europe, Canada and Australia.
ALung Technologies is the only company currently engaged in two landmark pivotal clinical trials regarding the treatment of patients with acute respiratory failure.
In one study, the Hemolung Respiratory Assist System (RAS) is being studied as part of the 1,140-patient REST Trial in the United Kingdom. The landmark trial, which is funded by the UK National Institute for Health Research (NIHR), is a study for patients with acute respiratory distress syndrome (ARDS). ALung is providing Hemolung systems and treatment kits to 40 hospitals participating in the study. The REST Trial, which was launched in 2015, is the world’s first and largest pivotal trial of extracorporeal carbon dioxide removal (ECCO2R) technology.
A second study, called the VENT-AVOID Trial, is a U.S.-based clinical trial to validate the safety and efficacy of the Hemolung RAS for the treatment of adults with severe acute exacerbation of chronic obstructive pulmonary disease (COPD). The U.S. FDA’s approval of its Investigational Device Exemption (IDE) makes ALung’s VENT-AVOID Trial the first pivotal trial of ECCO2R for treating patients with COPD exacerbations. Forty hospitals will enroll up to 800 patients in the trial, which was launched in 2017.