ALung Technologies announced today that it received FDA de novo clearance for its Hemolung respiratory support platform.
Pittsburgh-based ALung designed its Hemolung system to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) for patients with acute respiratory failure.
According to a news release, the de novo nod makes Hemolung the first and only ECCO2R device cleared by the FDA. Its indication covers respiratory support that provides ECCO2R from the patient’s blood for up to five days in adults with acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately or safely achieved using other available treatment options and continued clinical deterioration is expected.
The company touts Hemolung as a first-of-its-kind, comprehensive system for providing minimally invasive, low-flow ventilatory support through a single 15.5 French, central venous catheter at blood flows of 350 – 550 mL/min, offering a new tool to treat respiratory failure patients in a less invasive, less costly and less complex way.
ALung submitted data to the FDA from over 1,000 Hemolung patient treatments on clinical safety and more than 230 treatments on clinical performance outcomes to earn the de novo nod.
“This clinical data along with all of our pre-clinical data demonstrated to the FDA that the clinical benefits of the Hemolung for ECCO2R therapy has been substantiated,” ALung Chairman & CEO Peter M. DeComo said in the release. “We look forward to introducing this new and valuable technology to the clinical market.”
ALung is conducting the Vent-Avoid pivotal clinical trial for treating chronic obstructive pulmonary disease (COPD) and offering the platform for treating COVID-19 under an FDA emergency use authorization.