ALung Technologies said today its Hemolung RAS extracorporeal carbon dioxide removal device has been selected for use in the world’s 1st pivotal trial of ECCO2R technology used to treat patients with acute respiratory failure.
The U.K.’s National Institute for Health Research will supply $3.1 million (GBP £2.1 million) in funding for the 1,120 patient Rest trial, which looks to examine the effect of protective ventilation with veno-venous lung assist devices during respiratory failure.
The trial will be jointly led by Queen’s University and Belfast Health and Social Services Trust, the company said.
“Reducing ventilator pressures has been one of the most important interventions shown to improve outcomes in these critically ill patients. Use of these lung-protective ventilation strategies, however, leads to a critical accumulation of carbon dioxide in the blood. Carbon dioxide can be removed from the blood independently of the failing lungs with an extracorporeal device in a manner similar to kidney dialysis, thus enabling implementation of safer mechanical ventilation settings. We have shown through several pilot studies that the Hemolung RAS can safely and effectively meet this clinical need, and are very excited to embark on this pivotal study to determine the impact of this strategy on patient outcomes,” clinical and scientific affairs veep Laura Lund said in a press release.
ALung will provide its Hemolung systems and treatment kits to 40 hospitals participating in the study, the company said.
The Hemolung RAS won CE Mark clearance in the European Union in 2013 and is approved in 34 countries, including Canada and Australia. The device has not received FDA clearance for commercialization in the U.S.
“This broad implementation of extracorporeal CO2 removal in support of the study is possible because, unlike other technologies, the Hemolung RAS has been specifically designed to provide highly effective support, in a minimally invasive manner, with a degree of safety and simplicity that allows it to be used in a general medical ICU. We are honored to have been chosen by the study team as the exclusive technology partner for this very important project and look forward to its commencement next year,” CEO Peter DeComo said in prepared remarks.