The Ark Kidney System is a medical device for ex vivo normothermic perfusion intended to create the conditions that allow kidneys to be resuscitated and / or preserved prior to transplantation. It consists of a permanent unit, which is retained after each perfusion, and a disposable circuit called the Kidney Disposable Set (KDS), which must be replaced after perfusion to ensure sterile conditions.~It is a portable organ perfusion system designed to preserve a kidney by continuous perfusion of the donated organ with warm oxygenated perfusate supplemented with erythrocytes from the blood bank. The perfusion solution circulates continuously through the vascular network of the organ in a closed circuit. During perfusion, the system can monitor organ perfusion parameters, as well as the conditions of the perfusion solutions and the volume of urine generated during the perfusion.~The primary objective of the clinical study is to assess the viability, performance and safety of ex vivo normothermic perfusion with the Ark Kidney System in kidney transplantation from DCD and DBD donors.
A multicenter, prospective and open-label clinical investigation to evaluate the viability, performance and safety of ex vivo normothermic perfusion in kidney transplantation from DCD and DBD donors.