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, offer…