Paragonix Technologies has received U.S. Food and Drug Administration (FDA) clearance for its next-gen donor lung preservation system, BAROguard.
 
BAROguard combines the company’s advanced hypothermic preservation tech with automated, continuous, and active airway pressure control to ensure that an optimal temperature range and clinically recommended inflation pressure range for donor lungs are maintained from donor to recipient patient.
 
Donor lungs are currently preserved and transported in an inflated state from donor to recipient site. Current organ recovery techniques don’t reliably maintain and control lung inflation pressures in the clinically recommended range of 12-15 cmH₂O. Most are transported in aircraft, where ambient pressure changes can expose lungs to reach elevated pressure.
 
“The BAROguard Donor Lung Preservation System was designed to address these critical issues with an automated and easy to use active pressure management system,” Dr. Lisa Anderson, CEO and president of Paragonix told the press.
 
“Manually inflating donor lungs can be a highly variable process during lung donation. There is the belief that maintaining a consistent donor lung airway pressure can be useful for optimizing static preservation, especially when recovering organs over extended times or distances” added Dr. Jack Haney, Surgical Director, Lung Transplant Program from Duke Medical Center. “BAROguard offers the potential for significant advancement of lung preservation that we will be studying via the GUARDIAN registry.”
 
“At Paragonix, we believe that transplant surgeons should have maximum control over the organ transplant process. BAROguard now offers automated active control over donor lung airway pressures and automated donor lung temperature control, both of which are continuously reported out in real-time to the transplant team,” Dr. Lisa Anderson went on. “The FDA clearance of BAROguard is a major step in providing transplant teams with leading technology to enhance organ transplantation outcomes.”