Paragonix Reports First-in-Human Uses of KidneyVault Renal Perfusion System

Paragonix has completed the world’s first-in-human cases using its U.S. Food and Drug Administration (FDA)-cleared KidneyVault portable renal perfusion system.

These cases included successful transport of four donor kidneys to four separate medical institutions in the U.S. in a 24-hour period last December. The transplants were made possible through support of leading OPOs (organ procurement organizations), including LifeGift of Houston, Texas.

KidneyVault received FDA clearance in October 2024. The device provides convenient, end-to-end hypothermic perfusion for new levels of standardization that align with kidney allocation workflow.

OPOs and transplant centers can remotely monitor the device in real-time with a data-driven dashboard that shares perfusion parameters, temperature conditions, and other critical data at all times. The clinical community has come to rely on hypothermic machine perfusion devices to compensate for longer cold ischemia times by pumping a perfusate solution through the kidney to sustain viability in a controlled environment.

“Hypothermic perfusion increases the availability of high-quality donor kidneys nationwide,” said Yolanda Becker, MD, VP and chief medical officer at LifeGift. “However, historically, it was not always feasible to deliver every kidney on pump due to the distances traveled increasing cold ischemic times. LifeGift is now at the forefront of portable perfusion technologies that allow us to transport kidneys greater distances, by ground or commercial air, using a single controlled device from end-to-end. This hands-off solution provides the flexibility to deliver a kidney on pump to transplant centers.”

“We are fully committed to ensuring every patient has the best possible chance at life,” added Lisa Anderson, Ph.D., president of Paragonix Technologies. “This achievement highlights the potential of this one-of-a kind portable perfusion technology and sets a new standard for safety, reliability, and efficiency.”

Paragonix was acquired by Getinge in September 2024.