10/28/2024 | Press release | Distributed by Public on 10/28/2024 10:09
Press release | 10/28/2024
Paragonix Technologies, a leading organ preservation company recently acquired by Getinge, receives FDA clearance for the innovative transportable perfusion device KidneyVault, to optimize standard of care in kidney preservation.
"The process of kidney preservation and transportation is both challenging and delicate," says Dr. Jake Miles, Medical Director of Paragonix Technologies. "A portable perfusion device that allows for continuous monitoring and perfusion of donor kidneys during preservation has the potential to elevate the standard of care and reduce uncertainty in the preservation process."
Currently there are more than 106,000 patients on the national transplant waitlist in the United States, 86% of those patients are waiting for a kidney. Hypothermic machine perfusion, which uses a machine to continuously pump a specialized solution through an organ helps preserve it for transplantation. However, until now, there hasn't been a portable, user-friendly perfusion device to optimize the current standard of care in kidney preservation. The KidneyVault System was specifically developed to address this critical need by offering a state-of-the-art preservation device that integrates proven perfusion techniques with advanced digital monitoring and transport capabilities, simplifying the process from donation to recipient and ensuring integrity of organs following transport.
"With the alarming number of patients waiting for donor kidneys, it is crucial that the available organs are transported safely and arrive in optimal condition for transplantation," said Lisa Anderson, PhD, President of Paragonix Technologies. "The FDA clearance of the KidneyVault System is a significant milestone in equipping transplant teams with leading technologies to improve organ transplantation outcomes and move closer to addressing the urgent need for donor kidneys."
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. It can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.
For more information about Paragonix Advanced Organ Preservation devices, visit www.paragonix.com.
Media contact: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.