US-based organ transplant technology company Paragonix Technologies has received the US Food and Drug Administration (FDA) 510(k) approval for its portable donor kidney preservation system, KidneyVault.

KidneyVault represents Paragonix’s first perfusion device and combines its digital monitoring capabilities with portable hypothermic perfusion technology to protect donor kidneys.

The portable renal perfusion system is intended for pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and transplantation into a recipient.

It is designed to maintain the donor organ storage temperature between 4°C and 8°C for 24 hours.

Paragonix Technologies medical director Jake Miles said: “The process of kidney preservation and transportation is both challenging and delicate.

“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 Paragonix, there are more than 106,000 patients on the national transplant waitlist in the US, and 86% of them are waiting for a kidney.

Hypothermic machine perfusion technology uses a machine to continuously pump a specialised solution to help preserve an organ for transplantation.

However, a portable, user-friendly perfusion device to optimise the current standard of care in kidney preservation is not available until now.

Paragonix said its KidneyVault System was specifically developed to address the critical need for kidney preservation.

KidneyVault offers an organ preservation device that integrates proven perfusion techniques with advanced digital monitoring and transport capabilities.

Paragonix Technologies president Lisa Anderson said: “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.

“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.”

Last month, Swedish medical technology company Getinge closed the acquisition of Paragonix for $477m.