Bridge to Life has received FDA De Novo clearance for its VitaSmart hypothermic oxygenated perfusion (HOPE) system for liver transplantation.
According to Duluth, Georgia–based Bridge to Life, the FDA clearance enables the commercial use of VitaSmart for hypothermic oxygenated perfusion of donor livers following static cold storage and prior to transplantation. The De Novo clearance enables a clear, regulated pathway for U.S. transplant centers to incorporate HOPE protocols into clinical practice.
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The clearance was supported by results from a study that enrolled 219 recipients across 15 U.S. transplant centers. Bridge to Life plans a U.S. commercial launch of VitaSmart during the first quarter of 2026.
“This clearance represents a transformational milestone for Bridge to Life and an important advancement for liver transplantation in the United States,” Don Webber, CEO and President of Bridge to Life, said in a Jan. 20 news release.
“VitaSmart is the first FDA-cleared hypothermic oxygenated perfusion system for liver transplantation, and the labeling reflects FDA’s determination of safety and effectiveness, aligned with real-world transplant practice. We believe this will support adoption, contribute to improved organ utilization, and offer meaningful clinical and significant economic value to transplant programs.”
The FDA-cleared labeling for VitaSmart supports hypothermic oxygenated perfusion of donor livers prior to transplantation in both donation after brain death (DBD) and donation after circulatory death (DCD) donors, within defined donor criteria. Including DCD grafts mattered because they’re an increasingly important donor category for transplantations.
The labeling also allows for extended HOPE durations that could improve transplantation logistics coordination, avoid rushed implantations, and reduce risk of re-exposure to static cold ischemia.
“Having an FDA-cleared hypothermic oxygenated perfusion system commercially available represents an important development for transplant programs,” said Dr. Kristopher Croome, professor of surgery and transplant and hepatobiliary surgeon at Mayo Clinic Florida.
“The availability of VitaSmart’s HOPE technology under FDA-cleared labeling, supports ongoing efforts to optimize preservation strategies, particularly with DCD liver grafts. Without a fixed perfusion duration limitation this represents an important advancement and underscores the FDA’s recognition of hypothermic oxygenated perfusion as a safe and clinically meaningful approach to liver preservation, empowering transplant teams with greater flexibility to deliver the best possible care to patients in need.”
