Data from the GUARDIAN Registry, presented at the 45th ISHLT Annual Meeting, shows the Paragonix SherpaPak® Cardiac Transport System led to statistically significant improvements in short and long-term post-transplant survival and cardiac complications
WALTHAM, Mass.–(BUSINESS WIRE)–Paragonix Technologies, a leader in organ transplant technologies and organ procurement services, announces new research presented during the 45th ISHLT Annual Meeting and Scientific Sessions. The expansive study compared long-term outcomes of donor hearts preserved with the Paragonix SherpaPak® Cardiac Transport System, an FDA-cleared and CE-marked device, to those stored on conventional ice storage over four years post transplantation.
Drawing on data from the GUARDIAN-Heart Registry, the study compared four-year mortality rates between the SherpaPak System and ice storage in US adult heart transplant recipients. In a propensity-matched analysis, researchers found a 54% reduction in 4-year mortality (p=0.018), and an improvement in survival at each yearly interval compared to historical ice storage.1
- 72% Reduction in 1 Year Mortality (Ice – 23/243 (9.5%) vs SherpaPak – 2/243 (2.7%), p=0.003) 1
- 68% Reduction in 2 Year Mortality (Ice – 32/241 (13.3%) vs SherpaPak – 9/213 (4.2%), p<0.001) 1
- 52% Reduction in 3 Year Mortality (Ice – 39/235 (16.6%) vs SherpaPak – 13/165 (7.9%), p=0.010) 1
- 54% Reduction in 4 Year Mortality (Ice – 39/177 (22.0%) vs SherpaPak – 9/88 (10.2%), p=0.018) 1
Additionally, researchers found that hearts transported with a SherpaPak System had a 50% reduction in severe primary graft dysfunction (PGD) (p=0.017) and a 63% reduction in severe right ventricular dysfunction (RVD) (p=0.007). The study concluded that the utilization of the SherpaPak System for organ preservation was associated with improved post-transplant outcomes, including a statistically significant survival advantage over four years. 1
Researchers presented additional findings from the GUARDIAN-Heart Registry at the conference, which concluded:
- Compared to conventional ice storage, use of the SherpaPak System was linked to a lower development of cardiac allograft vasculopathy (CAV), one of the most common late-term morbidities in heart transplant. Researchers presented data that found that patients in the SherpaPak cohort had significantly lower rates of any CAV in years three and four, with year four exhibiting 17.7% (SherpaPak) vs. 23.6% (Ice) (p=0.047).2
- In an analysis of Global Adult Extended Criteria Donors, the SherpaPak System was associated with a reduction in post-transplant clinical complications, including a 26% reduction in post-transplant mechanical circulatory support (0.043), a 31% reduction in PGD (p=0.020), and a 61% reduction in severe RVD (p<0.001). 3
- A study on rehospitalizations in the first year after heart transplantation found a significant increase in freedom from all-cause rehospitalization (p=0.003), including cardiovascular-related rehospitalizations (p=0.017) using the SherpaPak System in comparison to ice storage. 4
“Our research indicates that the use of moderate, controlled hypothermia not only significantly reduced the risk of Severe PGD and severe RVD, but also significantly reduced mortality through 4 years post-transplant,” said Dr. David D’Alessandro, Director of Heart Transplantation and Ventricular Assist Devices at Massachusetts General Hospital.
«These landmark findings represent monumental progress in heart transplantation technology and research. The GUARDIAN Registry research data clearly demonstrates that patients whose donor hearts were preserved with the Paragonix SherpaPak experience a statistically significant improvement in outcomes,” said Lisa Anderson, Ph.D., President of Paragonix Technologies. “At Paragonix, we remain committed to working alongside the transplant community to ensure every donor gift has the greatest chance to save and sustain life.»
Paragonix is committed to working closely with transplant centers, organ procurement organizations, and healthcare professionals to ensure broad accessibility of its Advanced Organ Preservation technology, including the SherpaPak System, which is utilized across over 130 programs globally to preserve and protect donor hearts.
For more information about Paragonix Advanced Organ Preservation devices, please visit 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.
A Getinge company, 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.
About Getinge
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile processing and life science. Getinge employs approximately 12,000 people worldwide and the products are sold in more than 135 countries.
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References
- D’Alessandro et al., 2025 ISHLT Presentation 2025, Data on File
- Uriel et al., 2025 ISHLT Presentation 2025, Data on File
- Moayedifar et al., 2025 ISHLT Presentation 2025, Data on File
- Khush et al. 2025 ISHLT Presentation 2025, Data on File
Disclaimer
Comparison of Paragonix systems to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study funded and administered by Paragonix Technologies. The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.
Contacts
Media Contact:
Adam Lafreniere
Vice President, Marketing
[email protected]
