FDA Cleared New Heart Preservation System
The X°Port Heart Preservation System has received regulatory approval to support donor heart transport.
Updated on Sept. 22, 2026 in Heart Disease
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The FDA granted 510(k) clearance to the Traferox Technologies X°Port Heart Preservation System. The device allows for the transport of donor hearts kept at a temperature of 10°C.
Why it matters
Clinical evidence indicates that 10°C heart preservation reduces the risk of severe primary graft dysfunction while improving overall survival rates for transplant patients.
The system preserves donor hearts at a controlled 10°C for up to 4 hours using a cold storage solution. Vanderbilt University Medical Center has already successfully completed more than 150 procurements using this 10°C method.
The players
Traferox Technologies
This medical device company based in Mississauga, Ontario, specializes in organ preservation systems for transplant medicine.
Vanderbilt University Medical Center
This major medical research institution has conducted extensive clinical work using the 10°C heart preservation method.
Food and Drug Administration
This federal agency is responsible for protecting public health by regulating medical devices and ensuring the safety of healthcare products.
The details
The device utilizes static hypothermic preservation technology to maintain heart integrity during transport, requiring the use of a del Nido or equivalent cold storage solution. This clearance follows the manufacturer's successful commercial launch of the X°Port Lung system in 2025.
Timeline
September 22, 2026: The FDA granted 510(k) clearance for the X°Port Heart system.
Q3 2025: Traferox Technologies launched the X°Port Lung system in the United States.
Health Landscape
The regulatory clearance validates the clinical success demonstrated by Vanderbilt University Medical Center's 10°C heart procurement program. This approval marks a significant shift in organ transport technology, moving toward standardized hypothermic preservation protocols.
This development could improve post-transplant survival and decrease complications for patients requiring cardiac surgery. By extending the viability of donor hearts, the technology may also help transplant centers manage logistics more effectively during the procurement process.
The takeaway
Advancements in hypothermic preservation are increasingly central to improving outcomes in donor organ transport. Patients and families can monitor transplant success rates as hospitals adopt these new preservation technologies.
Further reading
Learn more about the latest innovations in transplant medicine in our Heart Disease section.
Source note: This article includes information reported by Financial Post.
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