US-based organ transplant technologies company Paragonix Technologies has completed the world’s first-in-human case using its BAROguard Donor Lung Preservation System.
BAROguard is the company’s latest donor lung preservation technology, which received the US Food and Drug Administration (FDA) 510(k) approval in August this year.
Dr Kunal Patel at Duke University Medical Center has protected a pair of donor’s lungs using the BAROguard System across the 600-mile transit.
The BAROguard System actively preserved and monitored the donor’s lungs for more than six hours to facilitate a life-saving transplant.
Together with Patel, the transplant team included thoracic surgeon Jacob Klapper, along with cardiothoracic fellows Aaron Williams and Dr Bailey Su.
Paragonix Surgical Services team procurement expert James Gramm has delivered the donor lungs to the Duke University Medical Center transplant team.
Kunal Patel said: “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 utilis ing new technologies.”
Duke lung transplant surgical director Matthew Hartwig said: “Clinical literature suggests that both the temperature and the inflation pressure of donor lungs can impact post-transplant outcomes.
“Controlling these critical variables, particularly with the number of complexities that exist within a lung transplant case, could improve patient outcomes.”
Paragonix said that its BAROguard is the first commercially available hypothermic preservation system designed based on its previous cardiothoracic and abdominal preservation technologies.
The system can automatically control the airway pressure of the donor lungs when outside the body during preservation and transportation.
It is designed to eliminate the traditional risks to donor lungs during transport by consistently maintaining the optimal temperature range and clinically recommended inflation pressure range.
The system transmits real-time temperature and airway pressure data to the transplant teams providing full visibility into the conditions of the lungs during their transport.
Paragonix Technologies CEO and president Lisa Anderson said: “This exciting milestone serves as a testament to the BAROguard System’s potential to revolutionize lung preservation and transport.
“We will continue to push the boundaries of innovation to provide more advanced tools for healthcare professionals and better outcomes for patients.”
