Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, has successfully completed the world’s first-in-human case utilizing its newest donor lung preservation technology, the BAROguard™ Donor Lung Preservation System, which received FDA 510(k) clearance in August 2023. The groundbreaking case, conducted by Dr. Kunal Patel at Duke University Medical Center, safely protected a pair of donor lungs across 600 miles. The BAROguard™ System actively preserved and monitored the donor lungs for over 6 hours on their journey to provide a life-saving transplant.
Building on the established legacy of Paragonix’s previous cardiothoracic and abdominal preservation technologies, the BAROguard system is the first commercially available hypothermic preservation system that is equipped to automatically control the airway pressure of donor lungs when outside the body during preservation and transportation. This new technology ensures that the donor lungs avoid the traditional risks that occur during transport by consistently remaining within the optimal temperature range and adhering to the clinically recommended inflation pressure range. The real-time transmission of temperature and airway pressure data to transplant teams grants full visibility into the conditions of the lungs during transport to the destined recipient.
“Clinical literature suggests that both the temperature and the inflation pressure of donor lungs can impact post-transplant outcomes,” said Dr. Matthew Hartwig, Surgical Director of Lung Transplant at Duke. “Controlling these critical variables, particularly with the number of complexities that exist within a lung transplant case, could improve patient outcomes.”
Dr. Kunal Patel, Assistant Professor of Surgery at Duke, requested the use of BAROguard for this inaugural case and echoed similar sentiments, stating, “This is an exciting time in the field of transplantation to address preservation conditions that were previously not controllable. We are steadfast in our commitment to advancing patient care, and our team is at the forefront of exploring and utilizing new technologies.”
Joining Dr. Patel in the operating room, the transplant team of this landmark case consisted of thoracic surgeon Dr. Jacob Klapper, as well as cardiothoracic fellows Dr. Aaron Williams and Dr. Bailey Su. The donor lungs were delivered to the team by Dr. James Gramm, an experienced procurement expert on the Paragonix Surgical Services team.
“This exciting milestone serves as a testament to the BAROguard System’s potential to revolutionize lung preservation and transport,” said Lisa Anderson, CEO and President of Paragonix Technologies. “We will continue to push the boundaries of innovation to provide more advanced tools for healthcare professionals and better outcomes for patients.
