Paragonix Technologies Debuts New Donor Liver Preservation System

Paragonix Technologies has launched the LIVERguard Donor Liver Preservation System and its clinical global registry, GUARDIAN-LIVER (Global Utilization And Registry Database for Improved preservAtion of doNor LIVERs) in the United States and Europe.

“Donor livers are being shared across large geographies,” said Lisa Anderson, Ph.D., president and CEO of Paragonix Technologies. “This means livers are broadly shared among organ procurement organizations and transplant teams and it creates an obvious need and opportunity to standardize methods of preservation. The LIVERguard system is designed to ensure consistent and repeatable standardized cold storage of livers, regardless of teams, time, geography, or the unforeseen. Further, Paragonix will be unrelentingly diligent in the pursuit of identifying and measuring the impact of advanced liver preservation with the GUARDIAN-LIVER global registry. The impact of both the GUARDIAN-HEART and -LUNG registries has been clear to transplant teams around the world. Insights gathered from the initial heart registry not only inform new approaches to organ preservation but show that preservation could be crucial in overcoming other considerations of the transplant procedure that may be challenging, such as donor and recipient characteristics, and ischemic time. Expanding this research into liver and the abdominal market is the next logical step and an exciting opportunity to better understand the impact of organ preservation conditions on patient outcomes.” 
 
The LIVERguard System provides a highly controlled environment for hypothermic liver preservation, coupled with real-time digital monitoring to safeguard a donor liver throughout the transplant journey from donation to transplantation. The LIVERguard System represents a fundamental advance over the use of ice and off-the-shelf coolers that have been the standard-of-care in organ transplantation for more than 50 years. U.S. and European abdominal transplant teams will now have access to a U.S. Food and Drug Administration (FDA)-cleared and CE marked hypothermic liver preservation device. 
 
The commercial availability of the LIVERguard system aligns with the launch of the GUARDIAN-LIVER global registry, a comprehensive study that seeks to evaluate a missing piece of the organ procurement process: the impact of methods and technologies used for liver preservation and transportation and their contribution to the clinical outcome and success of transplant surgery. At the outset of the program, 10 liver transplant centers have joined the GUARDIAN-LIVER Registry.
 
“We are very excited to be one of the first centers in this registry, evaluating this promising technology in organ preservation for our patients in desperate need of a liver transplant.” said Dr. Ali Zarrinpar, associate professor of Surgery in the Division of Transplantation and Hepatobiliary Surgery at the University of Florida.
 
Studies have shown ice storage can result in transport conditions close to 0°C, below the 4-8°C commonly cited as a standard in the literature.¹ The LIVERguard system provides a highly controlled transport environment validated to maintain temperatures of 4-8°C. The device’s performance is continuously reported to the user and is captured in a data log download following the procurement. 
 
Length of Cold Ischemic Time (CIT), the time the donor organ is out of the body, is commonly cited as a direct influence on outcomes in liver transplantation. Longer CIT is associated with an increased risk of a variety of clinical complications, including  increased risk of Primary Non-Function, increased Early Allograft Dysfunction, prolonged length of stay, and an increased risk of graft loss.^2-4 
 
Paragonix Technologies designs, produces, and sells FDA-cleared and CE marked organ preservation and transportation devices that safeguard organs during the journey between donor and recipient patients. 
 
References
¹ Villa R, et al. Transplantation. 2006
² Olthoff KM, et al. Liver Transpl. 2010 
³ Lozanovski VJ, et al. Front. Immunol. 2020 
⁴ Pan ET, et al. Liver Transpl. 2018