Paragonix Technologies receives FDA 510(k) clearance for KidneyVault portable renal perfusion system

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.

Getinge’s most recent acquisition, Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, has received US Food and Drug Administration (FDA) 510(k) clearance for its donor kidney preservation system, KidneyVault. The KidneyVault System is Paragonix’s first perfusion device, integrating its streamlined digital monitoring capabilities with portable hypothermic perfusion technology to protect donor kidneys during transport. This combination of advanced technologies further reinforces an ongoing commitment to improve and redefine the standard of care in transplant medicine.

“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:
Caroline Örmgård, Head of Public & Media Relations
Phone: +46 (0)10 335 0041
Email: caroline.ormgard@getinge.com

About Getinge and Paragonix Technologies
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.

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.