WALTHAM, Mass., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Paragonix Technologies, a pioneer in organ transplant technologies and services, announced today the publication of groundbreaking research on two-year post-transplant outcomes following heart transplantation. The study, published in The Journal of Heart and Lung Transplantation, compared traditional ice storage to the Paragonix SherpaPak® Cardiac Transport System, the leading FDA-cleared and CE-marked device for donor heart preservation and transport. Using data from the GUARDIAN-Heart Registry, the world’s largest clinical database dedicated to donor heart preservation, researchers analyzed the impact of preservation methods on long-term patient outcomes. Notably, this study marks the first time any medical device has demonstrated statistically significant improvements in survival following heart transplantation.
The analysis consisted of a total of 1,261 U.S. adult patients, which were matched using statistical propensity matching to create two cohorts of equal baseline characteristics to compare the use of the SherpaPak® System against traditional ice storage. The cohorts each consisted of 362 patients. Investigators reported statistically significant improvements in the cohort associated with utilization of the Paragonix SherpaPak System, including:
- 50% reduction in Severe Primary Graft Dysfunction, defined as the use of Mechanical Circulatory Support (MCS), excluding balloon pumps, within 24 hours post-transplant (p=0.008).
- 32% reduction in all post-transplant MCS, including MCS continued from pre-transplant throughout the post-transplant period (p=0.007).
- 44% reduction in Severe Right Ventricular Dysfunction (RVD) (p=0.047).
- 5% increase in two-year survival, equivalent to a 43% reduction in two-year mortality, marking a technological milestone in heart transplantation (p=0.042).
“With the publication of this analysis from the GUARDIAN-Heart Registry, we’ve now established that controlled, moderate hypothermic preservation can significantly impact not only early post-transplant outcomes but also longer-term outcomes of survival,” said Dr. Jacob Schroder, a lead investigator and Surgical Director for Advanced Heart Failure at Duke University Hospital. “This is the first study of any advanced heart preservation method – static or perfusion-based – to show a clear survival benefit. These findings underscore that maintaining precise, uniform temperatures is essential to prevent freezing injury and preserve donor heart viability.”
Paragonix is committed to working closely with transplant centers, organ procurement organizations, and healthcare professionals to ensure access to its Advanced Organ Preservation technology. Used in more than 50% of U.S. heart transplant cases and trusted by more than 75% of US cardiac transplant centers, the Paragonix SherpaPak System continues to set the standard for donor heart preservation and protection.
For more information about Paragonix Technologies, please visit paragonix.com.
About Paragonix Technologies
Paragonix Technologies, a Getinge company, is redefining how donor organs are protected and delivered, setting a new standard of care for transplantation worldwide. Built on the belief that every donated organ deserves the highest level of precision and respect, Paragonix partners with transplant centers and OPOs to improve outcomes through clinically proven preservation technologies and expert, hands-on procurement support.
Our nationwide transplant services provide 24/7 access to surgical recovery teams, logistics coordination, and clinical excellence — streamlining the recovery process and expanding access to life-saving organs. Combined with real-time digital monitoring, transparent data sharing, and the world’s largest preservation-focused clinical registries, Paragonix aims to deliver every possible advantage to healthcare providers and patients alike. For more information, visit www.paragonix.com.
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Media Contact: Adam Lafreniere Vice President, Marketing marketing@paragonixtechnologies.com
