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Findings from the GUARDIAN-Lung Registry highlight statistically significant reductions in acute rejection rates as well.
May 23, 2025
By: Michael Barbella
Managing Editor
Paragonix Technologies is sharing new lung preservation research that shows the benefits of its LUNGguard and BAROguard Donor Lung Preservation Systems compared to standard static ice storage.
Drawing on data from the GUARDIAN-Lung Registry—the first and largest global clinical database for studying lung preservation—the research indicates that Paragonix hypothermic preservation significantly reduced rehospitalizations and acute rejection after transplant.1
The registry data reflected significant improvements with the LUNGguard and BAROguard Donor Lung Perservation Systems over traditional static ice storage (the transplant preservation standard). The analyses add to the growing pool of research on Paragonix’s organ preservation technology that first began in 2020.
Comprising 1,160 lung transplant adults from 15 international transplant centers, investigators propensity-matched 608 patients into two comparative cohorts to compare advanced preservation directly against ice storage. Results from the analysis found the LUNGguard was associated with significantly fewer hospital readmissions at three months (p=0.023) and within one year (p=0.007) compared to ice.1 Significantly fewer rehospitalizations due to graft dysfunction were also observed at three months (p=0.005) and within one year (p=0.008), and lower rates of acute rejections were observed within three months (p=0.041) and six months (p=0.008) post-transplant.1
“The use of moderate hypothermia to preserve donor lungs demonstrated significant advantages in medium and long-term post-transplant outcomes,” said Dr. Nathaniel Langer, surgical director of Lung Transplantation at Massachusetts General Hospital and GUARDIAN-Lung investigator. “We observed lower rates of acute rejection and fewer hospital readmissions, which directly impacts the lives of our patients.”
Related: Paragonix Has 1st Pediatric Use of BAROguard Donor Lung SystemAdditionally, investigators studied the impact of the U.S. Food and Drug Admnistration (FDA)-cleared BAROguard System—a device featuring active airway pressure control—to its predecessor, the LUNGguard System. The analysis compared the two systems when utilized on cases that exceeded eight total hours of ischemic times. The research found the BAROguard System’s active pressure control was associated with improved outcomes compared to static hypothermic preservation alone, resulting in a significant reduction in the total duration of hospital stays exceeding 30 days (p=0.036).2
Additional findings from the GUARDIAN-Lung Registry included:
“These new findings from the GUARDIAN-Lung Registry reinforce the transformative impact of advanced preservation technologies on patient outcomes,” Paragonix Technologies President Lisa Anderson, Ph.D., said. “Reducing hospital readmissions and improving recovery times are critical measures of success in lung transplantation. The data show that Paragonix systems are setting a new standard for protecting donor lungs, especially as transplant teams face more complex logistics and extended preservation times.”
Paragonix Technologies develops, manufactures, and provides services to the organ transplant industry, establishing a novel approach to organ preservation. A Getinge company, Paragonix Technologies provides advanced organ preservation (AOP) devices that safeguard donor organs during the journey between donor and recipient patients. Its FDA-cleared and CE-marked devices incorporate clinically proven cold preservation techniques that allow physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with the company’s digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution.
Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile processing and life science. Getinge employs approximately 12,000 people worldwide and sells its in more than 135 countries.
Disclaimer: Comparison of Paragonix systems to ice storage, Paragonix data on file. GUARDIAN is a registered clinical study funded and administered by Paragonix Technologies. The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.
References1 Langer et al., ISHLT Presentation 2025, Data on file2 Bush et al., ISHLT Presentation 2025, Data on file3 Hartwig et al., ISHLT Poster Presentation 2025, Data on file4 Ceulemans et al., ISHLT Presentation 2025, Data on file
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