Traferox Technologies Receives FDA Clearance for X°Port Heart Preservation System
News related to:Traferox Technologies Inc · 2 min read
MISSISSAUGA, Ontario, Sept. 22, 2026 /CourierPR/ -- Traferox Technologies Inc. has received FDA clearance for its X°Port Heart Preservation System, marking a significant advancement in heart transplantation technology. The clearance allows the company to begin making 10°C heart preservation available to transplant centers across the United States, a method that has shown improved outcomes and donor utilization.
Rick Mangat, CEO of Traferox Technologies, expressed excitement about the milestone.
The X°Port Heart Preservation System enables static 10°C heart preservation during transport prior to transplantation. This method has been linked to improved early outcomes, including reductions in severe primary graft dysfunction and improved post-transplant survival compared to conventional ice storage and other hypothermic temperatures. According to published, peer-reviewed evidence, 10°C heart preservation has shown better results, even in transplants involving higher-risk donor hearts.
Vanderbilt University Medical Center was the first US 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 US, Vanderbilt has since completed more than 150 procurements using 10°C preservation and reported improved outcomes despite the use of higher-risk donor hearts.
Dr. Ashish Shah, Surgical Director of Vanderbilt’s heart transplant program, commented on the impact of 10°C preservation.
X°Port Heart builds on the US commercial launch of X°Port Lung in Q3 2025, which 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.
The introduction of X°Port Heart reflects Traferox's commitment to advancing organ transplantation through scientifically validated, clinically practical solutions that are easy to adopt and deliver sustainable value for healthcare systems worldwide. The company's growing portfolio includes technologies for donor lung and heart preservation and assessment, with a mission to improve transplant outcomes and increase access to life-saving organs for patients around the world.
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 storage and other hypothermic temperatures. The evidence is detailed in a study published in The Journal of Heart and Lung Transplantation, 45(8), 1229-1237, and a study by Williams, A. M., et al. (2026) in Circulation: Heart Failure.
With the FDA clearance of X°Port Heart, Traferox will begin making 10°C heart preservation available to transplant centers across the United States, further expanding access to this innovative technology.