FDA Clears Traferox’s 10°C Heart Preservation System

The U.S. Food and Drug Administration (FDA) has awarded 510(k) clearance to Traferox Technologies’ X°Port heart preservation system, which provides 10°C heart preservation before transplantation.

The FDA nod comes as evidence supporting 10°C heart preservation continues to expand. Peer-reviewed studies have associated the approach with lower rates of severe primary graft dysfunction and improved post-transplant survival compared with conventional ice storage and other hypothermic temperatures, including in transplants involving higher-risk donor hearts.

Vanderbilt University Medical Center was the first U.S. institution to clinically investigate 10°C heart preservation, building on the technology’s use in lung transplantation. The center has since completed more than 150 procurements using the approach and reported improved outcomes, including with higher-risk donor hearts.

X°Port Heart follows the U.S. launch of X°Port Lung in Q3 2025, which has since been adopted by seven of the 10 highest-volume U.S. lung transplant centers and more than half of U.S. lung transplant programs. With FDA clearance of X°Port Heart, Traferox will expand 10°C preservation to heart transplant centers nationwide.

Comments from Traferox and clinicians

Dr. Ashish Shah, Surgical Director of Vanderbilt’s heart transplant program: “10°C preservation has changed how we approach donor heart preservation. It is the standard in our institution for performing heart transplantation.”

Rick Mangat, CEO: “The FDA clearance of X°Port Heart marks an important milestone for Traferox and for the continued advancement of 10°C organ preservation. 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.”

Joe Kletzel, president: “The introduction of X°Port Heart reflects our commitment to advancing organ preservation through technologies grounded in robust science, designed for intuitive clinical integration, and built to deliver sustainable value for healthcare systems. With X°Port Heart, we are expanding that commitment to heart transplantation while building on the strong foundation established with the market leading X°Port Lung Preservation System and the newly launched TorEx Lung Perfusion System. Together, these technologies reflect our broader vision to provide transplant programs with clinically meaningful, practical solutions across the continuum of organ preservation.”