GUARDIAN-Lung Registry data presented at the 43rd ISHLT Annual Meeting & Scientific Sessions demonstrates statistically significant reduction in 1-year hospital readmission rates (p=0.018) for lung transplant recipients when utilizing the Paragonix LUNGguard Donor Lung Preservation System when compared to traditional ice storage of lungs1
CAMBRIDGE, MASSACHUSETTS, April 20, 2023 - Paragonix Technologies, Inc., the leading organ transplant company, presented impactful clinical data on the use of its Advanced Organ Preservation system, LUNGguard™, in a study presented at this year’s ISHLT Annual Meeting & Scientific Sessions. The study compares conventional ice-cold storage to the Paragonix LUNGguard™ system, using real-world multi-center data collected from the GUARDIAN-Lung Registry. The analysis illustrates that advanced lung preservation technology favorably influences post-transplant outcomes, including a 24% reduction in 1-year readmission rates (p=0.018).1 One-year readmission rates can be an indication of potential costly post-transplant complications, making the results of the study an important development for lung transplant centers.
The GUARDIAN-Lung data was collected from April 2019 to January 2023, consisting of 239 total patients (129 LUNGguard and 110 ice storage) from five (5) transplant centers across the United States. The results of the study show trends that indicate that transplant recipients who had their donor lungs stored in a Paragonix LUNGguard™ device experienced reductions in a variety of post-transplant complications, including numerical reductions in median ICU Length of Stay (4.8 days LUNGguard and 5.7 ice storage, p=0.10), and a reduction in Primary Graft Dysfunction (PGD Grade 3) at 72 hours (16.4% LUNGguard and 10.9% ice storage, p=0.25).1
“The data presented in this study suggest that patients who received lungs transported by a Paragonix LUNGguard may experience more favorable post-transplant outcomes as compared to the traditional method of storing the lungs over ice,” said Dr. John Haney, US Principal Investigator of the GUARDIAN-Lung study and Surgical Director of the lung transplant program at Duke University. “These results remain limited by the cohort size, but they are just the beginning of our efforts to study the effects of advanced lung preservation and optimize cold storage. We will continue to study the potential impact of Paragonix lung preservation technology in an effort to provide the most advanced care to end-stage lung failure patients on the transplant wait list.”
“Our goal at Paragonix is to not only improve transplant patient outcomes, but improve the transplant experience,” said Dr. Lisa Anderson, CEO and President of Paragonix Technologies. “The results of this study demonstrate the significant impact that advanced hypothermic preservation may have on transplant recipients. Now, over 25% of U.S. Lung Transplant Centers, as well as multiple centers across Europe, trust LUNGguard to safeguard donor organs en route to their waitlist patients. We will continue to innovate to ensure we provide the most clinically impactful technology to our surgeon community and their patients.”
The Paragonix LUNGguard™ system is an FDA-cleared and CE-marked medical device intended to be used to transport, store, and monitor donor lungs when in transit from donor to recipient. The device uses proprietary cooling technology to monitor and regulate the temperature of the donor organ. The GUARDIAN-Lung Registry analyzes the impact of donor organ temperature on patient outcomes.
Disclaimer
Comparison of Paragonix LUNGguard to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study (NCT04930289) funded and administered by Paragonix Technologies. At the time of this analysis, GUARDIAN contained data from 3 sites on 239 patients (110 ice transports and 129 Paragonix LUNGguard transports). The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.
References
L-428 Rev. 0