Paragonix Technologies, Inc. today announces that the University of Florida Health (UF Health) is the first to enroll a pediatric heart transplant recipient into the Company’s post-market registry, the Global Utilization And Registry Database for Improved preservAtion of donor HEARTs (GUARDIAN-HEART) Pediatric Registry. The GUARDIAN-HEART Pediatric research initiative joins two other prominent research efforts from Paragonix, the adult GUARDIAN-HEART registry for donor heart preservation and the GUARDIAN-LUNG registry for donor lung preservation, to work alongside clinical partners to collect real-world data on a missing piece of the organ donation and transplantation process: the impact of advanced preservation methods compared to standard methods.
UF Health’s Congenital Heart Center adopted the Paragonix SherpaPak® Cardiac Transport System in mid-2019 to safeguard donor hearts for the youngest transplant patients, ending its use of traditional storage methods involving standard ice coolers. The Paragonix SherpaPak’s hypothermic preservation techniques and novel suspension system provide unprecedented physical and thermal protection. Paragonix SherpaPak® CTS is the only commercially available FDA-cleared and CE-marked medical device for heart transportation and the only device to fit small pediatric donor hearts.
“Many infants, children, and adults have had successful outcomes after undergoing heart transplantation at University of Florida with donor hearts preserved with the Paragonix system,” said cardiothoracic surgeon Jeffrey Jacobs, MD, professor of surgery and pediatrics at University of Florida’s UF Health Congenital Heart Center and the pediatric principal investigator of the GUARDIAN-HEART Pediatric Registry. “The organ transplant community has spent decades studying and improving the techniques of preoperative care, surgery and postoperative care. The impact of improved donor heart preservation and transportation is a critical component of this ongoing research. A clinical registry dedicated to improving the preservation of the donor heart has the potential to save lives. We anticipate strong participation from centers across the globe. Under the leadership of Mark Bleiweis, MD, the University of Florida is one of the leading pediatric heart transplant centers and cardiac surgical programs in the world, and we are thrilled to be first to enroll a pediatric patient into GUARDIAN-HEART Pediatric.”
The global clinical study is registered at clinicaltrials.gov and is open to all pediatric heart transplant centers that are looking to analyze patient outcomes based on donor heart preservation methods. Clinical investigators from the enrolling centers will pool their data and analyze the differences in clinical outcomes of patients, focusing on short term post-transplant outcomes (within the first 48 hours), intermediate-term outcomes (within the first 30 days) and long-term outcomes (one-year survival).
“Pediatric care is a special practice held in the highest regard as these clinicians care for our most vulnerable patient population. Contributing to the quality of care children receive is of utmost importance to our team, and it is why this pediatric registry has been a top priority for our company,” said Lisa Anderson, Ph.D., CEO of Paragonix Technologies. “We are dedicated to supporting the transplant community – providers, patients and their families – by proving that more can be done to preserve the precious organs they have likely waited a very long time for.”
Paragonix has previously found that preservation method positively impacts an adult patient’s stay in the ICU1. In a recently presented multi-center clinical study, investigators found that donor hearts preserved by the Paragonix SherpaPak system – despite statistically significant increases in total ischemic time and travel distance – resulted in reduced ICU stays. An analysis of patients with extended ischemic times (greater than 3 hours) found the portion of patients in the ICU for two weeks or more was reduced by 50 percent in the Paragonix SherpaPak cohort and the portion of patients in the ICU for only a week or less was increased by more than double with the Paragonix system compared to ice storage.1
The award-winning Paragonix SherpaPak system has successfully transported nearly 900 adult and pediatric donor hearts since clinical launch in 2018. The GUARDIAN studies are the only and largest registries focused specifically on donor organ preservation. Paragonix is committed to understanding the science of organ preservation, investing in the research to understand the impact of devices such as its Paragonix SherpaPak® Cardiac Transport System, and LUNGguard™ Donor Lung Procurement System.
To learn more about the study, visit clinicaltrials.gov.
About Paragonix Technologies
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix SherpaPak CTS is the only commercially available FDA cleared and CE marked transport device for heart transportation.
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1- D’Alessandro et al., The Journal of Heart and Lung Transplantation 2021, Volume 40, Issue 4, Supplement , S127, April 01, 2021
Michael Tajima, VP Marketing