Pittsburgh-based ALung Technologies Inc. has received clearance from the U.S. Food and Drug Administration for its premiere product, the Hemolung Respiratory Assist System, which helps patients with acute respiratory distress.
The de novo review determined that the benefits of the medical device, developed out of the University of Pittsburgh, outweighs any risks. It's the first low-flow extracorporeal carbon dioxide removal technology that has received de novo clearance from the FDA, and is the result of years of development as well as clinical trials in the United States and the United Kingdom. There have been data from 1,000 treatments on clinical safety metrics and 230 patient treatments on clinical performance, ALung said.
"This clinical data along with all of our preclinical data demonstrated to the FDA that the clinical benefits of the Hemolung for ECCO2R therapy has been substantiated," said ALung Chairman and CEO Peter M. DeComo. "We look forward to introducing this new and valuable technology to the clinical market."
MORE: ALung was featured in the Pittsburgh Business Times' award-winning Small Business Big Mission series in 2020
Hemolung is used for carbon dioxide removal in the blood for as many as five days for people with acute respiratory failure. It's seen as an alternative for mechanical ventilation.
"The Hemolung will be an important new treatment modality for acute respiratory failure to avoid or mitigate the harms from invasive mechanical ventilation," said Dr. Steven Conrad, medical director of ALung and professor of medicine at Louisiana State University Health Sciences Center. "FDA clearance of the Hemolung is a game-changer for the treatment of these critically ill patients and will usher in a new era of extracorporeal lung support."
