UZ Leuven Lung Transplant Team utilized controlled hypothermic preservation provided by LUNGguard to preserve lungs between 4 and 8ºC, enabling next day recipient surgery
CAMBRIDGE, MASSACHUSETTS – February 8, 2023 – Paragonix Technologies, Inc., a leading organ preservation provider, announced today a pioneering lung transplantation case in which donor lungs procured overnight were preserved with the LUNGguard Donor Lung Preservation System, allowing for next day transplant surgery led by Prof. Dr. Laurens Ceulemans at UZ Leuven in Belgium. UZ Leuven Hospital, one of the most innovative and respected transplant centers in Europe, recently completed this landmark case, also marking the first use of the LUNGguard System in a pediatric lung transplant case anywhere in the world.
Overnight organ transplantation has been shown in clinical studies to be associated with a reduction in post-operative outcomes, including long term survival.1,2 A 2020 clinical study of 740 patients found overnight lung transplantations was associated with higher risks of major postoperative adverse events, (p=0.019), lower 5-year survival rates (p=0.024), and lower 5- year bronchiolitis obliterans syndrome–free survival (p=0.013).1
“The case was a bilateral lobar transplant, which is a complex procedure that should be avoided during nigh-time,” explained Prof. Dr. Ceulemans. “The LUNGguard System enabled us to safely prolong the ischemic time. This time-shift allows more in-house expertise from the whole team, including cardiac surgeons, anesthesiologists and scrub nurses. The procedure went fine, and the patient is home without oxygen, able to breathe like never before.”
Disclaimer: Extension of ischemic time in Paragonix LUNGguard should only be extended after assessment by a qualified attending physician.
The Paragonix LUNGguard™ Donor Lung Preservation System is the only FDA cleared and CE marked preservation device for hypothermic donor lung transportation. The LUNGguard incorporates Paragonix proprietary cooling technology to ensure thermal protection at 4-8°C for up to 40 hours for all donor lungs while providing a rigid and protective structure for physical safety. To date, LUNGguard has been used on over 400 lung transplant cases globally. Paragonix administers the largest post market clinical registry investigating the use of Advanced Organ Preservation compared to ice transport, with over 220 active enrollments for lung and over 1,500 active enrollments for heart.
UZ Leuven is one of several centers actively evaluating the use of LUNGguard technology as part of a strategy to address the logistical and clinical challenges of transplant procedures that are otherwise difficult to schedule. If implemented more broadly, such a strategy has the potential for centers to access donor lungs from further distances and entertain more matches for their waitlist patients given the flexibility with scheduled procedures, ultimately increasing the options for donor lungs available for their patients.
“We are excited to see our hypothermic technology used in this exciting new use case and look forward to seeing the impact this innovative approach has on clinical outcomes,” said Dr. Lisa Anderson, CEO and President of Paragonix. ”Overnight transplantation places tremendous stress on clinical staff and to be involved in providing a possible alternative is beyond thrilling. The physical and mental wellness of transplant surgeons and their staff are always at the forefront of our product development process and anything we can do to improve the efficiencies of these programs, we will continue to aggressively pursue.“
Paragonix LUNGguard™ Indications for Use
The Paragonix LUNGguard™ (LUNGguard™) is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.
The intended organ storage time for LUNGguard™ is up to 8 hours. Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.
For important safety information on the Paragonix LUNGguard System please visit: Important Safety Information
References
L-411, Rev 1