Clinical Evidence Points to Paragonix SherpaPak as Potential Solution to Expand Donor Heart Pool

In a study assessing high-risk heart donors at the 43rd ISHLT Annual Meeting & Scientific Sessions, GUARDIAN-Heart Registry data indicates a significant reduction in Primary Graft Dysfunction (PGD), a severe post-transplant complication, potentially allowing for an increase in donor hearts available for heart transplant patients.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc., the leader in organ preservation technology and research, has presented new groundbreaking data on the clinical impact of using Paragonix SherpaPak Cardiac Transport System to preserve donor hearts from extended criteria donors. An extended criteria donor is a term used in organ transplantation to describe a donor who may not meet the standard criteria of organ donation but is still considered suitable for donation. The use of extended criteria donor organs can increase the availability of transplantable organs but has also historically carried a higher risk of complications for the recipient. This recent study compared the use of traditional ice-cold storage to the Paragonix SherpaPak^® Cardiac Transport System, the leading FDA-cleared and CE-marked medical device for donor heart preservation, to measure the post-transplant outcomes of recipients who received an extended criteria donor heart. In the recipient group which utilized the Paragonix SherpaPak for organ preservation, the analysis found a significant reduction of 45% in Primary Graft Dysfunction (PGD). The results also showed a reduction of 55% in Severe PGD, a more severe complication shown to impact long-term survival of heart transplant recipients.

The study consisted of 330 patients, and the data was collected from nine transplant centers across the United States from October 2015 to January 2023 as part of the GUARDIAN-Heart Registry.

Key findings of this study include:

- 13.9% of patients who received a donor heart preserved on conventional ice storage reported Severe PGD, compared to 6.2% utilizing the Paragonix SherpaPak System (p=0.022).

- Significant reductions in all post-transplant mechanical circulatory support (36% reduction, p=0.012) significant reduction in newly placed ECMO/VAD post-transplant (49% reduction, p=0.03) utilizing the Paragonix SherpaPak system

- 92.9% 1 Year Survival in the Paragonix SherpaPak cohort

“I anticipate that the data presented in this study will have a significant impact on the way transplant surgeons evaluate extended criteria donors,” said Dr. Roxana Moayedifar, Cardiothoracic Surgeon at the Medical University of Vienna (Austria). “There is a strong desire in transplantation to conduct further research into extended criteria donors. The results of this study indicate that the use of the SherpaPak system can reduce post-transplant complications associated with high-risk donors. With an ever-increasing demand for donor hearts, we provide hope to many patients on the waiting list by safely increasing access to these extended criteria donors.”

“This study provides strong support for the utilization of Paragonix advanced organ preservation technologies with extended criteria donors,” said Dr. Lisa Anderson, CEO and President of Paragonix Technologies. “It is encouraging to share real-world data that shows how we can potentially expand the donor pool by utilizing this technology, and ultimately increase the number of life-saving heart transplants.”

About Paragonix Technologies

Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to preservation that represents a significant improvement over the traditional standard of care.

Paragonix Advanced Organ Preservation devices combine clinically-proven, stable cooling techniques with digital tracking and monitoring technologies to provide clinicians complete control and oversight throughout the donor organ journey. The clinical impact of Paragonix preservation technology is reinforced by the GUARDIAN clinical registries, the largest database of organ preservation data in the world that analyzes post-transplant outcomes in transplant recipients. 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 21 sites on 330 patients (137 ice transports and 193 Paragonix SherpaPak CTS transports). The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.

Paragonix SherpaPak^® Indications for Use

The Paragonix SherpaPak^® Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.

The intended organ storage time for the Paragonix SherpaPak™ Cardiac Transport System is up to 4 hours. Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

References

1. Moayedifar et al., ISHLT Presentation 2023, Data on file

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