Traferox Technologies today announced that the FDA has granted 510(k) clearance for the X°Port Heart Preservation System, a device that enables static 10°C (50°F) heart preservation during transport prior to transplantation.
“The FDA clearance of X°Port Heart marks an important milestone for Traferox and for the continued advancement of 10°C organ preservation,” said Traferox CEO Rick Mangat in a statement. “The strong clinical evidence supporting 10°C heart preservation, together with the successful adoption of 10°C preservation across leading lung transplant programs, has demonstrated the potential of this approach to improve donor organ preservation and transport. We look forward to working with transplant centers across the US to support the continued adoption of 10°C preservation in routine clinical practice”.
The clearance comes as clinical evidence supporting 10°C heart preservation continues to grow. Published, peer-reviewed evidence has linked 10°C heart preservation to improved early outcomes, including reductions in severe primary graft dysfunction and improved post-transplant survival compared to conventional ice storage1 and other hypothermic temperatures2, including in transplants involving higher-risk donor hearts.
Vanderbilt University Medical Center was the first U.S. institution to investigate 10°C heart preservation clinically, building on the success of 10°C preservation in lung transplantation. As the largest heart transplant center in the U.S., Vanderbilt has since completed more than 150 procurements using 10°C preservation and reported improved outcomes despite the use of higher-risk donor hearts.
“10°C preservation has changed how we approach donor heart preservation,” said Dr. Ashish Shah, Surgical Director of Vanderbilt’s heart transplant program. “It is the standard in our institution for performing heart transplantation.”
X°Port Heart builds on the U.S. commercial launch of X°Port Lung in Q3 2025, which the company said has since been adopted by 7 of the 10 highest-volume US lung transplant centers and more than half of all lung transplant programs in the US. This growing clinical adoption reflects the demand for preservation technologies that combine strong clinical evidence with practical benefits for transplant programs.
With the FDA clearance of X°Port Heart, Traferox will begin making 10°C heart preservation available to transplant centers across the United States.
