Getinge’s most recent acquisition, Paragonix Technologies, has recently received US Food and Drug Administration (FDA) 510(k) clearance for its donor kidney preservation system, KidneyVault, according to a recent press release.
The KidneyVault System is Paragonix’s first perfusion device, which it states integrates its “streamlined” digital monitoring capabilities with portable hypothermic perfusion technology to protect donor kidneys during transport. The company stated that 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 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.”
According to the press release, there are currently more than 106,000 patients on the national transplant waitlist in the USA, with 86% of those patients waiting for a kidney. Hypothermic machine perfusion, which uses a machine to continuously pump a specialised solution through an organ helps preserve it for transplantation. However, until now, there hasn’t been a portable, user-friendly perfusion device to optimise 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, president of Paragonix Technologies. “The US 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.
