#USA #Duluth #FDA #VitaSmart™ #Bridge to Life™

Bridge to Life™ Achieves FDA Clearance for VitaSmart™ Technology

In a groundbreaking announcement, Bridge to Life™ Ltd., a pioneer in organ preservation and perfusion technologies, recently secured De Novo clearance from the U.S. Food and Drug Administration (FDA) for its innovative VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System. This pivotal device is the first of its kind to be approved in the United States for the critical process of hypothermic oxygenated perfusion for donor livers, a significant leap forward for liver transplantation practices.

A Transformative Milestone for Transplantation

The clearance of the VitaSmart™ system opens new pathways for U.S. transplant centers to incorporate HOPE protocols into their clinical operations. This is a crucial development as it provides a regulated framework for hypothermic oxygenated perfusion in liver transplants, an essential procedure to enhance liver graft viability and function prior to transplantation. Don Webber, CEO and President of Bridge to Life™, emphasized that this breakthrough represents a transformational milestone for the company and an important advancement for liver transplantation.

Inclusion of DCD Donors

One of the standout features of the VitaSmart™ system is its implication for expanding the donor pool in liver transplantation. The FDA-cleared labeling specifically includes utilization of grafts from Donation after Circulatory Death (DCD) donors, who represent one of the largest opportunities to enhance available liver transplants. Dr. Kristopher Croome of the Mayo Clinic described the approval as a significant advancement, particularly for optimizing preservation strategies with DCD liver grafts.

Supporting Clinical Practice

The FDA’s approval validates the safety and effectiveness of the VitaSmart™ system, aligning its functionalities with real-world clinical practices. The cleared indication allows clinicians to make informed decisions regarding the duration of machine perfusion, reinforcing the utility of hypothermic oxygenated perfusion based on individual clinical scenarios and established protocols. This flexibility ensures that transplant teams can tailor their approaches to best serve the needs of both donors and recipients.

Evidence of Success

The FDA clearance was underpinned by compelling data derived from the Bridge to HOPE pivotal clinical trial. This extensive multicenter study tracked end-ischemic portal venous hypothermic oxygenated perfusion outcomes in adult liver transplants, involving 219 recipients across 15 transplant centers. The results showcased statistically significant improvements in early graft function and affirmed a robust safety profile for the VitaSmart™ system.

Economic and Operational Efficiency

The VitaSmart™ system is constructed to streamline operations within transplant centers, enhancing organ utilization and minimizing downstream resource utilization. Its design is centered around easy integration into existing workflows without necessitating transport-based perfusion systems, thus providing a capital-efficient means to advance organ preservation. Such operational efficiencies are crucial as transplant programs navigate complex clinical environments, ensuring optimal patient outcomes while managing resources effectively.

Acknowledgements

In closing, Don Webber expressed gratitude toward the multitude of investigators, transplant teams, and clinical staff who contributed to the success of the Bridge to HOPE study. This clearance is a testament to their collective commitment and rigor in advancing liver transplantation technology.

Bridge to Life™ Ltd. continues to lead the field of organ preservation through a comprehensive suite of solutions, including the VitaSmart™ Hypothermic Oxygenated Perfusion System, enhancing the quality and efficacy of donor organ preservation and transplantation practices.

For further details, visit Bridge to Life.