Paragonix Technologies, an innovator in organ transport and preservation solutions, has received US Food and Drug Administration (FDA) 510(k) clearance for its KidneyVault Portable Renal Perfusion System.
This clearance allows the KidneyVault system to be used in the US to improve the quality of kidney preservation and ultimately improve outcomes for patients undergoing kidney transplants.
The KidneyVault System marks Paragonix’s debut in perfusion devices, combining its advanced digital monitoring features with portable hypothermic perfusion technology to safeguard donor kidneys during transport and expand access to viable organs.
In a statement, Paragonix said with the FDA clearance, Paragonix becomes the only company in the US with regulatory approvals covering preservation systems for all five major solid organs used in transplant procedures.
Kidney transplants are critical, life-saving procedures for patients suffering from kidney failure. However, organ transportation poses a significant challenge, as kidneys are highly sensitive to temperature and lack oxygen when removed from the body.
Traditionally, kidneys are transported on ice in a standard cooler, exposing them to cold ischemia — an extended period where the organ receives no blood flow, which can affect its viability and function post-transplant.
Extended cold ischemia time (CIT) can lead to delayed graft function (DGF), a condition where the transplanted kidney does not work immediately and can require dialysis post-operation. In severe cases, prolonged CIT can contribute to kidney rejection or failure.
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In the US, over 106,000 patients are on the national transplant waitlist, with 86 percent waiting for a kidney.
Hypothermic machine perfusion — a process where a specialized solution is continuously pumped through an organ to preserve it for transplantation — has shown great promise for kidney transplants. But until now, there was no portable, user-friendly device to elevate the current standard of kidney preservation.
The KidneyVault System was developed to meet this need, providing a preservation device that combines proven perfusion techniques with advanced digital monitoring and transport capabilities, explained Paragonix. This integration streamlines the donation process, helping ensure donor kidneys arrive in optimal condition for recipients.
The KidneyVault system continuously pumps a preservation solution through the kidney, enhancing its viability for transplantation.
The KidneyVault system provides controlled temperature and pulsatile oxygenated perfusion, which allows the kidney to receive oxygen and nutrients while being transported.
By simulating blood flow, the KidneyVault minimizes cold ischemia time and reduces the likelihood of DGF, thereby helping improve the chances of successful kidney function immediately following transplantation.
The KidneyVault is designed to be portable and user-friendly, making it suitable for hospital staff to easily operate and transport. This is particularly beneficial for longer transportation routes, where there is a high risk of organ deterioration due to prolonged ischemic times.
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“The process of kidney preservation and transportation is both challenging and delicate,” said Dr. 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.”
In September, Paragonix partnered with the US Nationwide Organ Recovery Transport Alliance (NORA) to introduce a new donor organ courier service. By leveraging and integrating Paragonix’s organ preservation devices with NORA’s expertise in organ transport using commercial flights, the duo aims to create a robust logistics network to ensure timely delivery of donor organs across the country.
Paragonix’s product portfolio includes a range of devices for organ preservation and transport. In June, the FDA cleared its PancreasPak device, which is designed to preserve donor pancreases during transport.
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