FDA clears Paragonix KidneyVault portable renal perfusion system

Paragonix Technologies this week announced it received FDA 510(k) clearance for its KidneyVault donor kidney preservation system.

KidneyVault is Paragonix’s first perfusion device. The company designed it to streamline digital monitoring capabilities with portable hypothermic perfusion technology to help protect donor kidneys during transport. The system also expands the kidney donor pool. Paragonix said it is the only company with U.S. regulatory clearance for all five solid organs used in transplant procedures.

“The process of kidney preservation and transportation is both challenging and delicate,” said 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.”

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