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Expansive Clinical Study Finds Improved Outcomes in Heart Transplant Patients Utilizing Paragonix Advanced Organ Preservation

By: Paragonix Technologies, Inc. via Business Wire

September 07, 2023 at 09:00 AM EDT

GUARDIAN Registry study of over 500 heart transplant patients published in American Society for Artificial Internal Organs Journal (ASAIO) shows a 67% reduction (p=0.011) in Severe PGD (Primary Graft Dysfunction).¹

Paragonix Technologies, Inc., a leading organ transplant company, announced today the publication of groundbreaking research from a clinical study on patient outcomes following heart transplant surgery. The multi-center study compared the use of Paragonix SherpaPak^® Cardiac Transport System, the leading FDA-cleared and CE-marked donor heart preservation and transport device, to the use of conventional cold storage using ice in the preservation of donor hearts. Published in The American Society for Artificial Internal Organs (ASAIO), the study utilized data collected by the GUARDIAN-Heart Registry, the world’s largest clinical database dedicated to donor heart preservation, to analyze post-transplant outcomes and the impact on organ preservation methods on transplant patient health.

The US multi-center analysis of GUARDIAN Registry data included 569 adult patients who received heart transplants between October 2015 and January 2022. A propensity matched analysis showed a statistically significant (67% reduction p=0.011) in Severe Primary Graft Dysfunction (PGD), a severe post-transplant complication, utilizing SherpaPak compared to alternative methods.¹

Several other post-operative improvements were noted by the propensity matched study in favor of the SherpaPak cohort:

Significant 67% reduction in Post-transplant ECMO (extra corporeal membrane oxygenation) /VAD (ventricular assist device) use in the first 24 hours post-transplant (p=0.011)¹
Trending 30% reduction in all post-transplant MCS (Mechanical Circulatory Support) (p=0.098) and trending improvements in one-year survival (88.4% conventional cold storage vs 94.0% SherpaPak, p=0.10)^.1

“The findings of this study should impact decision making related to the type of preservation method utilized for heart transplant surgeries at the highest levels as it fundamentally challenges the decades long status quo of using ice storage for transporting donor hearts,” said Dr. Yasuhiro Shudo, Clinical Assistant Professor, Cardiothoracic Surgery at Stanford Medicine. “Particularly, in the post-allocation change era, with increasing travel distances and ischemic times, advanced hypothermic organ preservation is an important resource for transplant centers to consider.”

“The ongoing results of the GUARDIAN-Heart Registry have shown advanced preservation to be a potential game-changer for heart transplant patients. The results of our analysis found that post-transplant rates of severe primary graft dysfunction, a serious post-transplant complication, are significantly reduced by 67% when advanced hypothermic preservation was used compared to traditional ice storage methods. These findings are a testament to the potential impact of advanced preservation in heart transplantation.”

"Our investments in ongoing large data collection efforts and associated multi-center studies are paying off for transplant patients around the globe," said Dr. Lisa Anderson, President and CEO of Paragonix Technologies. "At Paragonix, our top priority is to improve patient care. With the vast body of clinical evidence reported out this year and the resulting broad adoption of our technology by the clinical community, it is clear that there is a new standard of care for heart transplant patients."

To learn more about Paragonix Technologies, visit their website at www.paragonix.com.

About Paragonix Technologies

Paragonix Technologies is a leading 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. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit www.paragonix.com.

Disclaimer

Comparison of Paragonix SherpaPak to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study (NCT04141605) funded and administered by Paragonix Technologies. At the time of this analysis, GUARDIAN contained data from 10 sites on 569 patients (255 ice transports and 314 Paragonix SherpaPak CTS transports). The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly. In this analysis, US adult cohorts were matched using statistical propensity matching to create cohorts of equal baseline characteristics (150 ice transports and 150 Paragonix SherpaPak CTS transports)

References

1.Shudo, Y. et al. A Paradigm Shift in Heart Preservation: Improved Post-Transplant Outcomes in Recipients of Donor Hearts Preserved with the SherpaPak System. ASAIO 2023

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