KidneyVault Portable Renal Perfusion System Gets FDA 510(k) Clearance

Paragonix Technologies has received US Food and Drug Administration 510(k) clearance for its donor kidney preservation system, KidneyVault. This is the company’s first perfusion device.

In hypothermic machine perfusion, a machine continuously pumps a specialized solution through an organ to help preserve it for transplantation. Although this method has demonstrated benefits for kidney transplantation, a portable, user-friendly perfusion device did not previously exist. KidneyVault offers a state-of-the-art preservation device that integrates perfusion techniques with advanced digital monitoring and transport capabilities to streamline the process from donation to recipient and ensure donor organs arrive in optimal condition.