KidneyVault Perfusion Technology Expands the Donor Pool by Increasing Access to Medically Complex Kidneys

By: Paragonix Technologies, Inc. via GlobeNewswire

September 02, 2025 at 09:00 AM EDT

WALTHAM, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Paragonix Technologies, a leader in advanced organ preservation and transplant logistics, reports an extraordinary case at the Tampa General Hospital Transplant Institute in which a donor kidney underwent continuous hypothermic machine perfusion on the KidneyVault^® Portable Renal Perfusion System for over 30 hours, and was successfully transplanted following a total cold ischemic time (CIT) of over 46 hours. This case highlights the expanding capabilities of modern preservation technology in overcoming traditional ischemic time constraints.

The donor kidney was initially accepted by a transplant center but subsequently declined due to scheduling limitations. As a result, the organ reached exhaustion on the national donor list, a status that typically results in the discard of the donor organ. In a last-minute effort to deliver on the wishes of the donor, the local organ procurement organization (OPO) initiated outreach to alternative centers, emphasizing the benefits of the utilization of KidneyVault for continuous perfusion of the organ. Ultimately, the organ was accepted and successfully transplanted by Dr. Chloe Wang, Abdominal Transplant Surgeon at the Tampa General Hospital Transplant Institute after a 2,058 nautical mile direct flight via commercial air travel. The patient was later successfully released without complications, including the avoidance of delayed graft function.

Under typical conditions, donor kidneys are maintained in hypothermic preservation using either ice or machine perfusion and transplanted with under 24 hours of cold ischemia, with a study in 2022 reporting more than 80% of donor kidneys meeting these criteria.¹ The same study found CIT beyond 36 hours was uncommon, with a limited amount of transplantations following more than 40 hours (1.8%) of CIT documented.¹ These extended ischemic times are associated with increased risk of delayed graft function and long-term complications, reinforcing the importance of advanced preservation to mitigate risk.

Hypothermic machine perfusion represents a significant advancement over static cold storage by continuously circulating preservation solution through the organ, reducing cellular injury, and potentially mitigating ischemia-reperfusion injury.² The KidneyVault System, cleared by the FDA in October 2024, is engineered for continuous, end-to-end hypothermic perfusion with integrated real-time remote monitoring. Its portable design supports logistical flexibility while maintaining consistent preservation conditions, even over long periods of preservation.

With kidney transplant candidates representing approximately 86% of the national transplant waitlist—nearly 90,000 individuals in 2024—the demand for effective organ utilization strategies remains critical. Technologies such as the KidneyVault System are instrumental in increasing transplant opportunities, particularly for marginal or logistically complex donor organs.

Dr. Kiran Dhanireddy, Vice President and Chief of the Tampa General Hospital Transplant Institute, commented:

“Tampa General Hospital is firmly committed to utilizing technology in the best interest of our patients. Our collaboration with Paragonix across all solid organ programs enables us to evaluate and utilize donor organs from greater distances and with increased medical complexity. Advanced preservation technologies directly support our shared mission to increase access and maximize transplant opportunities.”

For more information about Paragonix Technologies, please visit 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 realtime organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit www.paragonix.com.

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Media Contact:
Adam Lafreniere
VP, Marketing
marketing@paragonixtechnologies.com

References

Lum, Erik L. et al, Cold Ischemia Time, Kidney Donor Profile Index, and Kidney Transplant Outcomes: A Cohort Study. Kidney Medicine. November 2022.
4. Tingle SJ, Thompson ER, Figueiredo RS, Moir JAG, Goodfellow M, Talbot D, Wilson C, Cochrane Database of Systematic Reviews 2024, Issue 7

Disclaimers

The Paragonix KidneyVault^® Portable Renal Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for the preservation, transportation, and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ.

The Paragonix KidneyVault^® Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.

Donor kidneys exceeding clinically accepted 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.