Rachel Klemovitch, Assistant Editor04.08.24
Paragonix Technologies has announced the full commercial launch of its BAROguard Donor Lung Preservation System. This follows the device’s positive response in its limited market release and is now available for transplant centers and organ procurement Organizations across the United States.
In August of 2023, Paragonix received FDA clearance for the device and conducted its first-in-human case in November 2023 at Duke University Medical Center. Duke Health, Massachusetts General Hospital, Johns Hopkins Medicine, UCSF Health, and UCLA Health deployed the BAROguard System during its limited market release.
This is a first-of-its-kind device that combines clinically proven hypothermic preservation techniques with active airway management control so that donor lungs maintain optimal conditions during transport. BAROgurad is equip with built-in tracking and real-time reporting for surgeons and transplant teams to have access to the organ’s conditions throughout transit.
“Traditional lung preservation does not provide transplant teams with any information about the actual conditions experienced by the organ,” explained Dr. Nathaniel Langer, MD, MSC, Surgical Director, Lung Transplantation at Massachusetts General Hospital. “Unlike any other organ, lungs must hold air, so they are susceptible to damage from both over and under inflation during transport. The introduction of a device that both actively manages airway pressure and provides real-time data on internal temperature+- conditions during transport is an exciting advance that I hope will increase the availability of quality donor lungs to transplant programs around the country.”
The device launches in advance of the 44th ISHLT (International Society for Heart and Lung Transplantation) Annual Meeting and Scientific Sessions. At ISHLT, Paragonix will exhibit the BAROgurad System.
Data collected from the commercial use of the BAROguard device will contribute to the renowned GUARDIAN-Lung study, a post-market observational registry intended to evaluate the clinical outcomes of patients who have donor lungs preserved with Paragonix lung preservation devices versus other storage methods.
“The commercial launch of BAROguard represents a significant breakthrough for the organ transplantation industry,” said Paragonix Technologies President and CEO, Dr. Lisa Anderson. "We are immensely pleased with the success it has already achieved, and we are excited to offer this game-changing technology nationwide to help transplant surgeons and their teams to innovate the standard of care in transplantation."
In August of 2023, Paragonix received FDA clearance for the device and conducted its first-in-human case in November 2023 at Duke University Medical Center. Duke Health, Massachusetts General Hospital, Johns Hopkins Medicine, UCSF Health, and UCLA Health deployed the BAROguard System during its limited market release.
This is a first-of-its-kind device that combines clinically proven hypothermic preservation techniques with active airway management control so that donor lungs maintain optimal conditions during transport. BAROgurad is equip with built-in tracking and real-time reporting for surgeons and transplant teams to have access to the organ’s conditions throughout transit.
“Traditional lung preservation does not provide transplant teams with any information about the actual conditions experienced by the organ,” explained Dr. Nathaniel Langer, MD, MSC, Surgical Director, Lung Transplantation at Massachusetts General Hospital. “Unlike any other organ, lungs must hold air, so they are susceptible to damage from both over and under inflation during transport. The introduction of a device that both actively manages airway pressure and provides real-time data on internal temperature+- conditions during transport is an exciting advance that I hope will increase the availability of quality donor lungs to transplant programs around the country.”
The device launches in advance of the 44th ISHLT (International Society for Heart and Lung Transplantation) Annual Meeting and Scientific Sessions. At ISHLT, Paragonix will exhibit the BAROgurad System.
Data collected from the commercial use of the BAROguard device will contribute to the renowned GUARDIAN-Lung study, a post-market observational registry intended to evaluate the clinical outcomes of patients who have donor lungs preserved with Paragonix lung preservation devices versus other storage methods.
“The commercial launch of BAROguard represents a significant breakthrough for the organ transplantation industry,” said Paragonix Technologies President and CEO, Dr. Lisa Anderson. "We are immensely pleased with the success it has already achieved, and we are excited to offer this game-changing technology nationwide to help transplant surgeons and their teams to innovate the standard of care in transplantation."