Bridge to Life™ Celebrates FDA Clearance for VitaSmart™ Technology
In a significant achievement for the organ transplantation field, Bridge to Life™ Ltd. has attained FDA De Novo clearance for its innovative VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System. This groundbreaking clearance marks the establishment of a new regulatory framework for hypothermic oxygenated perfusion in liver transplants across the United States.
The FDA's approval unlocks the potential for commercial use of VitaSmart™. This system enhances the viability of donor livers after they have undergone static cold storage and before transplantation, thus paving the way for transplant centers in the U.S. to integrate HOPE protocols into their medical practices.
"This clearance signifies a pivotal advancement for Bridge to Life and for liver transplantation as a whole in the U.S.," shared Don Webber, CEO and President of Bridge to Life™ Ltd. "VitaSmart™ stands as the first FDA-cleared system for hypothermic oxygenated perfusion specifically for liver transplant procedures, with labeling that substantiates compliance with safety and efficacy standards in real-world clinical settings. We anticipate that this development will encourage broader usage of organs and provide substantial clinical and economic advantages to transplant programs."
Enhancing Liver Donation Opportunities
The occurrence of Donation after Circulatory Death (DCD) donors presents a significant opportunity to broaden the donor pool available for liver transplantation. The integration of DCD grafts into the FDA-cleared labeling illustrates a growing emphasis on preservation methods that uphold the health of these grafts prior to surgical implantation.
According to Kristopher Croome, MD, a prominent hepatic surgeon at Mayo Clinic Florida, the emergence of an FDA-cleared hypothermic oxygenated perfusion system is crucial for transplant programs. "The availability of VitaSmart’s technology bolsters ongoing endeavors to refine preservation techniques, particularly for DCD grafts," he said.
Approval Reflecting Clinical Needs
The FDA clearance outlines hypothermic oxygenated perfusion protocols applicable to donor livers before transplantation, which includes both Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) scenarios, adhering to established donor criteria.
Crucially, the FDA's indication does not limit the duration for machine perfusion, suggesting that medical professionals can utilize hypothermic oxygenated perfusion guided by clinical judgment and established standards.
The VitaSmart™ system offers various advantages:
- Integrates seamlessly with existing transplant workflows.
- Provides flexibility with preservation strategies before surgery.
- Utilizes a center-friendly, non-transport-based method for hypothermic perfusion.
These qualities position VitaSmart™ as a commercially viable platform, facilitating wide adoption across various U.S. transplant programs without complicating operational processes or increasing costs.
Clinical Evidence Validation
The support for the FDA clearance is backed by findings from the Bridge to HOPE pivotal clinical trial—a multicenter, randomized controlled study designed to evaluate end-ischemic portal venous hypothermic oxygenated perfusion in liver transplantation. This study involved 219 recipients across 15 U.S. transplant centers, accommodating diverse extended-criteria donor populations.
The compelling outcomes demonstrate significant early graft function improvements paired with a robust safety profile, which were instrumental in securing FDA's De Novo classification.
Practicality for Transplant Centers
The VitaSmart™ system is designed to enhance operational efficiency and clinical outcomes in transplant environments. Key operational benefits include:
- Boosting organ utilization rates.
- Reducing resource allocation in subsequent procedures.
- Simplifying workflow without the requirement for transport-based perfusion.
- A capital-efficient, scalable solution for advanced organ preservation.
Such advantages are essential as transplant programs strive to optimize clinical outcomes while managing resource constraints effectively.
Technology Tailored for Adoption
The VitaSmart™ System provides hypothermic oxygenated perfusion by cooling donor livers to regulated hypothermic temperatures and ensuring oxygenated perfusion fluid is delivered before transplantation. Its design prioritizes reliability, simplicity, and user-friendliness, supporting versatility across a multitude of transplant environments.
As noted by Webber, gratitude extends to all investigators, transplant teams, and clinical staff members involved in the Bridge to HOPE study and the entire Bridge to Life team, whose commitment has made this achievement possible. The clearance signifies years of methodical planning and teamwork, which proves essential for transformative advancements in organ transplantation.
About Bridge to Life™ Ltd.
Bridge to Life™ Ltd. stands as a world leader in organ preservation solutions, offering a comprehensive portfolio that embodies innovation and reliability. Their product line includes Belzer UW®, EasiSlush®, and the pioneering VitaSmart™ Hypothermic Oxygenated Perfusion System. This organization collaborates closely with transplant centers and organ procurement entities globally, dedicated to advancing preservation science and supporting life-saving organ transplants.
Frequently Asked Questions
What is the VitaSmart™ Hypothermic Oxygenated Perfusion System?
The VitaSmart™ system is a medical device designed for hypothermic oxygenated perfusion of donor livers prior to transplantation.
What does FDA clearance signify?
The FDA clearance indicates that the device meets safety and efficacy standards for clinical use in liver transplant procedures.
How does this system enhance DCD liver utilization?
This system supports preservation strategies tailored for organs from DCD donors, thereby expanding their use in transplantations.
What are the benefits of VitaSmart™ for transplant programs?
VitaSmart™ streamlines workflows, enhances organ viability, and can contribute to better clinical outcomes, all while reducing operational complexity.
Who can use the VitaSmart™ technology?
The technology is designed for use in transplant centers and can be adopted across various clinical settings engaged in liver transplantation practices.
