FDA Cleared Heart Preservation System for Transplants
The newly approved device maintains donor hearts at 10°C to support better survival outcomes for transplant patients.
Updated on Sept. 22, 2026 in Heart Disease
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The FDA has granted 510(k) clearance to the Traferox Technologies X°Port Heart Preservation System, a device designed to keep donor hearts viable for up to 4 hours. This technology is now slated for rollout to transplant centers throughout the United States.
Why it matters
By preserving donor hearts at 10°C rather than traditional methods, this system aims to improve post-transplant survival rates and reduce the incidence of severe primary graft dysfunction. These improvements offer a significant advancement in the logistics of organ transplantation.
Clinical data supporting the 10°C preservation method includes over 150 successful procurements performed by Vanderbilt University Medical Center. The findings show that this temperature range is associated with improved post-transplant survival and reduced primary graft dysfunction.
The players
FDA
The federal agency responsible for protecting public health by regulating medical devices and ensuring the safety and effectiveness of new healthcare technologies.
Traferox Technologies
A medical device company headquartered in Mississauga, Ontario, that specializes in organ preservation systems for transplantation.
Vanderbilt University Medical Center
A leading academic medical center that has conducted extensive clinical procurements using the 10°C preservation method.
The details
The X°Port system utilizes static hypothermic preservation to maintain donor hearts at a controlled 10°C during transport. To function, the process requires clinicians to use a del Nido or equivalent cold storage solution. This method effectively slows the metabolic rate of the heart tissue during the critical window between recovery and transplantation.
Timeline
September 22, 2026: FDA granted 510(k) clearance for the X°Port Heart Preservation System.
Q3 2025: Traferox Technologies launched the X°Port Lung system in the United States.
Health Landscape
The introduction of the X°Port Heart system marks a shift toward specialized temperature-controlled storage in organ donation. It follows the successful adoption of the X°Port Lung system, which is currently in use at 7 of the 10 highest-volume transplant centers in the United States.
For patients awaiting a heart transplant, these technological advancements help ensure higher-quality donor organs and better surgical outcomes. If you or a loved one are on a transplant list, discuss the local facility's preservation protocols with your surgical team.
The takeaway
Advancements in organ preservation are critical for enhancing the success of life-saving heart transplants. Patients and families can track institutional updates regarding surgical outcomes by consulting directly with their transplant center's cardiac care team.
Further reading
For more on the latest advancements in cardiac care, visit the Heart Disease section.
Source note: This article includes information reported by Financial Post.
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