Paragonix Technologies has announced FDA 510(k) clearance for its KidneyVault system, a portable renal perfusion device designed to improve donor kidney preservation during transport. This clearance marks a significant advancement in organ transplantation technology, addressing the critical need for enhanced preservation methods.
KidneyVault: Advancing Kidney Preservation
The KidneyVault system combines digital monitoring capabilities with portable hypothermic perfusion technology. This integration aims to safeguard donor kidneys during transportation, ensuring they arrive in optimal condition for transplantation. The system's portability and ease of use are designed to streamline the preservation process from donation to recipient.
Jake Miles, medical director of Paragonix Technologies, emphasized the challenges of kidney preservation and transportation, stating, "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."
Addressing the Critical Need for Donor Kidneys
According to Paragonix, more than 106,000 patients are on the national transplant waitlist in the U.S., with 86% of those patients awaiting a kidney transplant. Hypothermic machine perfusion, which involves continuously pumping a specialized solution through an organ, has demonstrated significant benefits in kidney transplantation. KidneyVault addresses the need for a user-friendly, portable perfusion device to optimize kidney preservation.
Streamlining the Transplantation Process
KidneyVault simplifies the kidney preservation process by integrating proven perfusion technologies with advanced digital monitoring and transport capabilities. This ensures that donor organs are transported safely and arrive in optimal condition for transplantation. Lisa Anderson, President of Paragonix, highlighted the importance of this advancement, stating, "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. 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."
Paragonix's Expanding Portfolio
The FDA clearance of KidneyVault follows other recent positive developments for Paragonix, including the first pediatric use of its BAROguard lung preservation system and the acquisition of Paragonix by Getinge for $477 million in September. Paragonix is now the only company with U.S. regulatory clearance for preservation technologies across all five solid organs used in transplant procedures.
