New International Study Reports Extension of the Donor Lung Transplantation Window
12 Mar 2024
WALTHAM, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc., a pioneer in organ transplant products and services, announces the landmark publication of the first clinical manuscript assessing the use of FDA-cleared advanced organ preservation technology to significantly extend ischemic times, a term referring to the sensitive window of time between organ recovery and transplantation. Prolonged periods of uncontrolled preservation can risk detrimental effects on the viability of the tissue or organ; however, safely extending ischemic times beyond fifteen hours can facilitate potential new avenues that surgeons can harness to significantly enhance access to life-saving transplants for patients. This milestone publication lays a strong foundation for future clinical applications in organ preservation and transplantation. For example, presenting a means to better accommodate longer transportation times, overnight bridging, or optimizing case scheduling during the day.
'Through the provision of optimal preservation conditions, we can effectively extend ischemic time, thereby unlocking new possibilities and potentially reaching a broader spectrum of patients.'
The retrospective analysis was conducted by three internationally recognized lung transplantation centers, including UZ Leuven Hospital (Belgium), Motol University Hospital (Czech Republic), and Massachusetts General Hospital (United States). During the six-month study period, the LUNGguard® Donor Lung Preservation System was utilized to preserve donor lungs for over 15 hours in 13 separate instances. The standard of care for preserving donor lungs typically utilizes a conventional cooler of ice, with an ischemic time over 6 hours often considered a higher risk factor for transplant outcomes. Longer ischemic times increase the risk of primary graft dysfunction, a serious complication that can occur after lung transplantation. Given the historically acknowledged risks associated with prolonged ischemic times on uncontrolled ice storage, the clinical investigators analyzed the outcomes of the qualified 13 patients to examine the impact of utilizing controlled hypothermic storage.
Despite the prolonged preservation times and complex case dynamics including high-risk recipients and extended criteria donors, the study reported 0% instance of PGD-3 at 72 hours. The use of the controlled hypothermic device allowed the teams to remotely monitor the preservation temperature throughout the entire period, reporting an average probe temperature of 7°C across all 13 donor lungs. The device’s proprietary cooling technology and data reporting capabilities allowed full transparency into critical case insights, ensuring a reliable and consistent thermal environment within clinically recommended and FDA-cleared parameters.
“The use of controlled hypothermic storage in scenarios that extend beyond fifteen hours has demonstrated significant promise with favorable short-term outcomes,” said Professor Laurens Ceulemans, Assistant Professor of Surgery and Deputy Head of Clinic in the Department of Thoracic Surgery at UZ Leuven. “Through the provision of optimal preservation conditions, we can effectively extend ischemic time, thereby unlocking new possibilities and potentially reaching a broader spectrum of patients.”
Disclaimer or Indications of Use for the Paragonix LUNGguard Donor Lung Preservation System
The Paragonix LUNGguard® (LUNGguard® ) is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for LUNGguard® is up to 8 hours.
Donor lungs 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.
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 temperature 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.
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References:
Ceulemans, et al. Extended Ischemic Time (> 15 Hours) Using Controlled Hypothermic Storage in Lung Transplantation: A Multicenter Experience Running head: Extended Ischemic Time in Lung Transplantation, Journal of Heart and Lung Transplantation, (2024)
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