Instructions for Use

The Paragonix KidneyVault® Portable Renal Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for the preservation, transportation, and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The Paragonix KidneyVault® Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours. Donor kidneys exceeding clinically accepted hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.