FDA Clears 10°C Donor-Heart Preservation System | Sept 22, 2026
FDA Clears 10°C Donor-Heart Preservation System | Sept 22, 2026
• FDA clearance: Traferox X°Port Heart for “static donor-heart preservation at 4–10°C for up to 4 hours”.
• Why 10°C? Vanderbilt University Medical Center /USA clinical data showed better early outcomes versus conventional ice storage; the evidence is retrospective/observational.
• Vanderbilt -Heart Transplant Program : The center has extensive clinical experience with 10°C donor-heart preservation; Reported >150 heart transports using this approach.
Sources:
Traferox Technologies — FDA clearance announcement, Sept 22, 2026
Traferox Technologies Inc. Receives FDA Clearance for the X°Port Heart Preservation System