BAROguard is a next-generation donor lung preservation system, designed to provide optimal temperature range and a clinically recommended inflation pressure range to donor lungs, throughout the journey, from donor to recipient patient
Paragonix gets FDA approval for BAROguard system. (Credit: Robina Weermeijer on Unsplash)
US-based organ transplant company Paragonix Technologies has received the US Food and Drug Administration (FDA) approval for BAROguard, its next-gen donor lung preservation system.
BAROguard is designed to deliver an optimal temperature range and a clinically recommended inflation pressure range to donor lungs, throughout the journey, from donor to recipient patient.
The system combines the company’s existing advanced hypothermic preservation technology with automated continuous and active airway pressure control.
The combination of advanced technologies will further help improve and redefine the standard of care within transplant medicine, said the medical device company.
Paragonix CEO and president Lisa Anderson said: “The BAROguard Donor Lung Preservation System was designed to address these critical issues with an automated and easy-to-use active pressure management system.”
According to the organ transplant company, current clinical practice involves the preservation and transportation of donor lungs in an inflated state from donor to recipient site.
However, current organ recovery techniques lack reliable maintenance and control over lung inflation pressures within the clinically recommended range of 12-15cmH2O.
The changes in ambient pressure may expose the lungs to elevated pressure, which may increase the risk of pulmonary barotrauma, according to respiratory management studies.
Paragonix said that its BAROguard System provides automated active control over donor lung airway pressures and automated donor lung temperature control, which is continuously reported to the transplant team in real time.
Duke Medical Center lung transplant program surgical director Jack Haney said: “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 overextended times or distances.
“BAROguard offers the potential for significant advancement of lung preservation that we will be studying via the GUARDIAN registry.”
Earlier this year, Paragonix announced the first paediatric use of its LUNGguard Donor Lung Preservation System in the Time Shift lung transplantation case.