CAMBRIDGE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announces the launch of its clinical global registry, GUARDIAN-LUNG (Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs). The GUARDIAN-LUNG study is unlike any lung donation registry as it seeks to evaluate a missing piece of the organ donation process: the impact of methods and technologies used for lung preservation and transportation on the success of transplant surgery.
The clinical study is registered at clinicaltrials.gov and is open to all lung transplant centers that are looking to analyze patient outcomes based on donor lung preservation methods. Clinical investigators from the enrolling centers will pool their data and analyze the differences in clinical outcomes of patients who receive donor lungs preserved either in the Paragonix LUNGguard™ Donor Lung Preservation System or with traditional methods of storing in a consumer cooler on ice. The study will focus on short term post-transplant outcomes (within the first 48 hours), intermediate-term outcomes (within the first 30 days) and long-term outcomes (1-year survival).
“This unique registry will provide critical and contemporary data on lung transplant outcomes, with the potential to impact the process for both donors and recipients,” said Matthew Hartwig, MD, MHS, Chief of Lung Transplant Research at Duke University Health System. “Our program sees this registry as an important opportunity to make vast strides in how certain procedural details, including organ transportation, can improve patient outcomes. All programs should be seeking the opportunity to participate and contribute to this study.”
Paragonix has previously found that preservation method does positively impact a patient’s stay in the ICU1. The GUARDIAN-LUNG study follows the success of Paragonix’s first registry, GUARDIAN, for evaluating donor heart preservation, comparing historic ice storage to the Paragonix SherpaPak® Cardiac Transport System. In a recently presented multi-center clinical study, investigators found that the donor hearts preserved by the Paragonix SherpaPak system had statistically significant increases in total ischemic time and travel distance, meaning the organ was able to be effectively preserved outside a human body longer and be retrieved from donors at a greater distance from the recipient. An analysis of the patients with extended ischemic times found the portion of patients in the ICU for two weeks or more was reduced by 50 percent in the Paragonix SherpaPak cohort, and the portion of patients in the ICU for only a week or less was increased by more than double with the Paragonix system compared to ice storage.1
“Transplant surgery presents many unknowns and complexities. We’ve invested in these studies to better support the transplant teams and patients by providing insights that may help them in handling the dynamics of the entire operation, from transport to transplant,” said Lisa Anderson, Ph.D., CEO of Paragonix Technologies. “The first results of our GUARDIAN registry for heart preservation and transplantation sets an exciting and optimistic stage for what we can achieve for further supporting lung preservation and transplantation.”
“The importance of both the heart and lung registries is clear to transplant teams around the world: the more data we have on the variables of the entire transplant process, the more lives we can potentially save,” said Errol Bush, MD, Surgical Director, Advanced Lung Disease and Lung Transplant Program and Associate Professor of Surgery at Johns Hopkins Medicine. “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.”
The LUNGguard System provides a highly controlled environment for hypothermic lung preservation, coupled with real-time digital monitoring to safeguard donor lungs throughout the entire transport journey via the Paragonix App where, historically, communication and coordination has been difficult. Paragonix’s centralized communication and data transfer capabilities are fully compatible with and integrated into the usage of the LUNGguard system. This system is based on the same architecture as the award-winning Paragonix SherpaPak system that has successfully transported over 800 donor hearts since clinical launch in 2018.
The GUARDIAN studies are the only and largest registries focused on donor organ preservation. Paragonix is committed to understanding the science of organ preservation, investing in the research to understand the impact of devices such as its SherpaPak® Cardiac Transport System and LUNGguard™ Donor Lung Procurement System.
To learn more about the study, visit clinicaltrials.gov.
About Paragonix Technologies
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix SherpaPak® CTS is the only commercially available FDA cleared and CE marked transport device for heart transportation.
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- D’Alessandro et al., The Journal of Heart and Lung Transplantation 2021, Volume 40, Issue 4, Supplement , S127, April 01, 2021