Paragonix Technologies has announced the completion of the first-in-human cases utilising the US Food and Drug Administration (FDA)-cleared KidneyVault portable renal perfusion system.
The cases included the successful transport of four donor kidneys to four separate medical institutions across the USA in a 24-hour period last December.
The KidneyVault portable renal perfusion System received FDA clearance in October of 2024. The device is designed for convenient end-to-end hypothermic perfusion. Organ procurement organisations and transplant centres 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.
“Hypothermic perfusion increases the availability of high-quality donor kidneys nationwide,” said Yolanda Becker, vice president and chief medical officer at LifeGift, an organ procurement organisation in Houston, USA. “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 centres.”
The successful first-in-human use of the KidneyVault system marks a major milestone in Paragonix Technologies’ mission to transform the standard of care in transplantation, the company says in a press release.
“We are fully committed to ensuring every patient has the best possible chance at life,” said Lisa Anderson, 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.”