Paragonix Technologies this week announced it received FDA 510(k) clearance for its KidneyVault donor kidney preservation system.
KidneyVault is Paragonix’s first perfusion device. The company designed it to streamline digital monitoring capabilities with portable hypothermic perfusion technology to help protect donor kidneys during transport. The system also expands the kidney donor pool. Paragonix said it is the only company with U.S. regulatory clearance for all five solid organs used in transplant procedures.
“The process of kidney preservation and transportation is both challenging and delicate,” said Jake Miles, medical director of Paragonix Technologies. “While existing perfusion devices are clinically effective, they are complex to operate and challenging to transport. A novel portable perfusion device that allows for continuous monitoring and perfusion of donor kidneys during preservation has the potential to elevate the standard of care and reduce uncertainty in the preservation process, ultimately providing more hope for patients on the waitlist.”
According to Paragonix, there are more than 106,000 patients on the national transplant waitlist in the U.S., and 86% of those patients need a kidney.
Hypothermic machine perfusion uses a machine to continuously pump a specialized solution through an organ to help preserve it for transplantation. The method has shown significant benefits for kidney transplantation. However, Paragonix Technologies said there has not been a portable, user-friendly perfusion device to optimize the current standard of care in kidney preservation.
KidneyVault addresses the clinical need by offering a preservation device that uses proven perfusion technologies with advanced digital monitoring and transport capabilities. It simplifies the process from donation to recipient and ensures donor organs arrive in optimal condition.
“With the alarming number of patients waiting for donor kidneys, it is crucial that the available organs are transported safely and arrive in optimal condition for transplantation,” said Paragonix President Lisa Anderson. “The FDA clearance of the KidneyVault System is a significant milestone in equipping transplant teams with leading technologies to improve organ transplantation outcomes and move closer to addressing the urgent need for donor kidneys.”
The FDA clearance follows a slew of positive news from the company recently, including the early October announcement that Paragonix completed the first pediatric use of its BAROguard lung preservation system. Paragonix was also acquired by Getinge in September for $477 million.
