Study: LIVERguard System Reduces Post-Transplant Complications

Real-world data collected from the GUARDIAN-Liver Registry indicate Paragonix Technologies’ organ preservation system, LIVERguard, reduced post-transplant complications better than conventional ice static cold storage.

The data came from a study comparing conventional ice static cold storage to the Paragonix LIVERguard system. The analysis showed that advanced donor liver preservation technology favorably reduced the incidence of early post-transplant outcomes such as early allograft dysfunction and acute kidney injury, despite facing longer recovery distances and cold ischemic time compared to the ice cohort. 

The analysis collected GUARDIAN-Liver data from October 2022 to March 2025, extracting information from 898 total patients in U.S. transplant centers. The study analyzed the impact of advanced hypothermic preservation on a propensity-matched cohort of 410 total patients (205 LIVERguard vs. 205 Ice). Notably, the chorts’ baseline characteristics were similarly matched in all aspects except distance traveled, where the LIVERguard cohort experienced greater overall distances (280+314 nautical miles LIVERguard vs. 195+269 Ice, p=0.003.) Despite facing significantly broader geographic transit, the LIVERguard cohort still demonstrated a 51% reduction in early allograft dysfunction (26.0% vs. 12.5%, p<0.001).¹

The research strongly indicates there is no cold ischemic time where ice provides benefit over controlled hypothermic preservation with LIVERguard. The LIVERguard System may extend cold ischemic times while reducing the risk of early allograft dysfunction.

“The accumulation of clinical data in the GUARDIAN-Liver Registry is presenting more and more evidence against the use of ice storage,” said Dr. Kiran Dhanireddy, U.S. principal investigator of the GUARDIAN-Liver study and vice president/chief of the TGH Transplant Institute. “The LIVERguard System is proving to be a flexible and effective means to provide controlled hypothermic preservation in the modern era as allocation strategies evolve and transplant programs seek to safely grow their program.”

The Paragonix LIVERguard system is a U.S. Food and Drug Administration (FDA)-cleared medical device intended to be used to transport, store, and monitor donor livers when in transit from donor to recipient. The device uses proprietary cooling technology to regulate the donor organ’s temperature. The GUARDIAN-Liver Registry analyzes the donor organ temperature impact on patient outcomes.

Paragonix Technologies is a developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. 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 and medically trusted 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 its products are sold in more than 135 countries.

References
¹ Dhanireddy, et al. WTC 2025 Presentation
² Data on File, SRTR (www.srtr.org)