Summary: Paragonix Technologies has received FDA 510(k) clearance for its KidneyVault System, a portable kidney preservation device combining hypothermic perfusion with digital monitoring. This FDA approval makes Paragonix the only U.S. company with clearances for all five solid organ transplants.
Key Takeaways:
- The KidneyVault System provides continuous monitoring and preservation during kidney transport, aiming to improve outcomes for patients awaiting transplants.
- Paragonix’s FDA clearance addresses a critical need in organ transplantation, particularly given the high demand for kidneys in the U.S.
Paragonix Technologies, a provider of organ transplant technologies and services, has received FDA 510(k) clearance for its KidneyVault System, a donor kidney preservation device.
Innovative Kidney Preservation Technology
The KidneyVault System is Paragonix’s first perfusion device, combining digital monitoring capabilities with portable hypothermic perfusion technology to protect donor kidneys during transport and expand the donor pool. This FDA clearance makes Paragonix the only company with U.S. regulatory clearances for all five solid organs used in transplants.
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“The process of kidney preservation and transportation is both challenging and delicate,” said Jake Miles, MD, medical director of Paragonix Technologies. He noted that while existing devices are effective, they are complex to operate and transport. KidneyVault offers continuous monitoring and perfusion during preservation, potentially elevating the standard of care and reducing uncertainty in the preservation process.
Addressing the Critical Demand for Donor Kidneys
With over 106,000 patients on the U.S. national transplant waitlist and 86% awaiting kidneys, the need for reliable preservation methods is urgent. The KidneyVault System was designed to meet this need by combining proven perfusion techniques with digital monitoring, simplifying the process from donor to recipient to ensure kidneys arrive in optimal condition.
“With the alarming number of patients waiting for donor kidneys, it is crucial that available organs are transported safely,” said Lisa Anderson, PhD, president of Paragonix. “The FDA clearance of the KidneyVault System is a significant milestone in equipping transplant teams with leading technologies to improve outcomes and address the urgent need for donor kidneys.”