Paragonix Technologies
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients
GUARDIAN-Lung is a post-market, observational registry of adult and pediatric lung transplant recipient patients whose donor lungs was preserved and transported within the LUNGguard. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria. About 3,500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study at about 25 clinical sites. Candidates that fit the eligibility criteria…
Inclusion Criteria: * Donor and donor lungs matched to the prospective recipient based upon institutional medical practice * Registered male or female primary lung transplant candidates including pediatric candidates Exclusion Criteria: * Donor and donor lungs that do not meet institutional clinical requirements for transplantation * Patients who are incarcerated persons (prisoners) * Patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas) * Patients who are receiving multiple organ transplants
The LUNGguard is an FDA cleared and is a CE-marked medical device 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 the LUNGguard is up to 8 hours.
The BAROguard (the "System") is ultraportable hypothermic preservation and transport system intended for use with donor lungs. BAROguard is a legally marketed, FDA cleared medical device in the United States. The intended organ storage time for BAROguard™ is up to 8 hours.