The KidneyVault device pumps a preservation solution continuously through the organ to help preserve it for transplantation. Image credit: Luuuusa / Shutterstock.

Paragonix Technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) for its portable donor kidney preservation system, KidneyVault.

KidneyVault is Paragonix’s first perfusion device. The system uses portable hypothermic perfusion technology to help protect donor kidneys during transport. The device also has digital monitoring capabilities to allow for continuous monitoring of donor kidneys to ensure its viability.

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“The process of kidney preservation and transportation is both challenging and delicate. While existing perfusion devices are clinically effective, they are complex to operate and challenging to transport,” said Dr Jake Miles, medical director of Paragonix Technologies.

“A novel 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, ultimately providing more hope for patients on the waitlist.”

The KidneyVault pumps a preservation solution continuously through the organ to help preserve it for transplantation. Paragonix’s portfolio consists of multiple organ preservation and transport devices. In June, the FDA cleared its PancreasPak device for preserving donor pancreases during transportation.

In September, the company partnered with the US Nationwide Organ Recovery Transport Alliance (NORA) to launch a new donor organ courier service. The partnership aims to establish a logistic network by pairing Paragonix’s suite of organ preservation devices with the organ transport company using commercial flights, to ensure organs are delivered across the US.

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Paragonix was acquired by Swedish medical device company Getinge for $477m last month. Getinge paid approximately $253m in cash upon completion, with the remaining amount to be paid out as milestone-based payments.

Multiple companies are developing organ preservation devices. Last month, Bridge to Life presented data from Italian trials for its mechanical perfusion device, HOPE [hypothermic oxygenated perfusion], showing that the use of the device improved outcomes in redo-liver transplantation.

In July 2023, OrganOx raised £25m ($32m) to develop its normothermic machine perfusion (NMP) device that preserves donor livers in a functioning state for up to 24 hours before transplant.

In December 2023, Vascular Perfusion Solutions received a $25,000 grant from the Southwest-Midwest National Pediatric Device Innovation Consortium (SWPDC) to develop its VP.S Encore cardiac preservation technology into a portable paediatric device.