FDA Approves KidneyVault, a Portable Renal Perfusion System

Paragonix Technologies, a company specializing in organ transplant technologies and organ procurement services, received FDA 510(k) clearance for its donor kidney preservation system, KidneyVault. The KidneyVault System is Paragonix’s first perfusion device, integrating its digital monitoring capabilities with portable hypothermic perfusion technology to protect donor kidneys during transport and expand the donor pool.

The company said the additional FDA clearance makes it the only company with U.S. regulatory clearances for all five solid organs used in transplant procedures.

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

Hypothermic machine perfusion, which uses a machine to continuously pump a specialized solution through an organ to help preserve it for transplantation, has shown significant benefits for kidney transplantation. But there hasn’t been a portable perfusion device to optimize the current standard of care in kidney preservation. The KidneyVault System was specifically developed to address this need by offering a preservation device that integrates proven perfusion techniques with digital monitoring and transport capabilities, simplifying the process from donation to recipient and ensuring donor organs arrive in optimal condition.

"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. “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.”