MISSISSAUGA, Ontario — September 22, 2026

Traferox Technologies Inc. announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the X°Port® Heart Preservation System, a medical device designed for static hypothermic preservation of donor hearts at 4°C to 10°C for up to four hours during transport before transplantation. The clearance expands Traferox’s organ preservation portfolio into heart transplantation and enables the company to begin making 10°C heart preservation available to transplant centers across the United States.

X°Port Heart Enables 10°C Donor Heart Preservatio

X°Port Heart is designed to preserve donor hearts at 10°C during transportation, building on clinical evidence supporting controlled-temperature organ preservation. Traferox cited published peer-reviewed evidence associating 10°C heart preservation with improved early outcomes, including reductions in severe primary graft dysfunction and improved post-transplant survival compared with conventional ice storage and other hypothermic preservation temperatures. The system is indicated for static hypothermic preservation using del Nido or an equivalent cold-storage solution.

Vanderbilt Reports Clinical Experience With 10°C Preservation

Vanderbilt University Medical Center has conducted more than 150 heart procurements using 10°C preservation, according to Traferox, following its clinical investigation of the approach in the United States. The company said Vanderbilt reported improved outcomes despite the use of higher-risk donor hearts. The growing clinical experience provides additional evidence supporting the use of controlled-temperature preservation in heart transplantation, while X°Port Heart is intended to facilitate practical adoption of the approach across transplant centers..

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Traferox Expands Organ Preservation Portfolio

The FDA clearance of X°Port Heart builds on Traferox’s commercial launch of X°Port Lung in 2025, which the company says has been adopted by seven of the 10 highest-volume U.S. lung transplant centers and more than half of U.S. lung transplant programs. Traferox is also developing the TorEx Lung Perfusion System, expanding its portfolio across donor organ preservation and assessment. With X°Port Heart now cleared in the United States, the company plans to support transplant programs seeking clinically integrated technologies for heart preservation and transportation.

Source :Traferox Technologies,, press release