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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apr 28, 2021–
Paragonix Technologies introduced the presentation of the First Report of the GUARDIAN Registry 1 on the International Society for Heart and Lung Transplantation 2021 Annual Meeting.
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Improved medical outcomes for coronary heart transplant recipients have been introduced on the Worldwide Society for Coronary heart and Lung Transplantation from a global research on the Paragonix SherpaPak® Cardiac Transport System (Picture: Enterprise Wire)
The GUARDIAN study is the biggest multi-center, worldwide registry particularly targeted on donor coronary heart preservation. Medical investigators from the primary 5 enrolling facilities collaborated to pool their knowledge and analyze the variations in medical outcomes of 224 sufferers who obtained donor hearts preserved both within the Paragonix SherpaPak ® Cardiac Transport System or with conventional ice storage.
Dr. David D’Alessandro, Surgical Director of Coronary heart Transplantation at Massachusetts Normal Hospital, introduced the research outcomes and summarized the authors’ conclusions that, “Coronary heart preservation using the Paragonix SherpaPak CTS compares favorably to ice storage preservation on this registry evaluation. Regardless of unfavorable donor and recipient traits within the [Paragonix] cohort of sufferers, early medical outcomes together with Intensive Care Unit (ICU) size of keep are improved.”
The investigators reported that the donor hearts preserved by the Paragonix SherpaPak had statistically important will increase in whole ischemic time and journey distance 2. Complete ischemic time, the time a donor coronary heart is out of the physique earlier than implanted in a recipient, is a identified danger issue for destructive outcomes. Regardless of this elevated danger the authors discovered important reductions in ICU size of keep, with median ICU durations decreased by three days, within the Paragonix SherpaPak cohort.
An evaluation of sufferers with prolonged ischemic instances, these larger than three hours, discovered much more pronounced favorable variations. On this group, the portion of sufferers within the ICU for 2 weeks or extra was decreased by 50% within the Paragonix SherpaPak cohort, and the portion of sufferers within the ICU for under every week or much less have been greater than double in comparison with ice storage.
“We’re extremely inspired and gratified by the presentation of those outcomes. We lengthen our gratitude to all clinicians and sufferers who’re contributing knowledge to the GUARDIAN registry as we pledge our robust dedication to an information pushed strategy in offering revolutionary instruments to the transplant neighborhood. Additional, our ongoing knowledge assortment effort and the becoming a member of of many facilities in the US and in Europe throughout 2021 will make this database an essential useful resource to assist information medical follow. Our group is dedicated to advancing the science of donor coronary heart preservation,” stated Lisa Anderson, Ph.D., CEO of Paragonix Applied sciences.
1 – GUARDIAN is a registered medical research https://clinicaltrials.gov/ct2/show/NCT04141605. On the time of this evaluation, GUARDIAN contained knowledge from 5 websites on 223 sufferers (99 ice transports and 124 Paragonix SherpaPak CTS transports). The info from the registry is descriptive, not statistically powered, and never pre-specified. The data needs to be interpreted accordingly.
2 – The Paragonix SherpaPak™ Cardiac Transport System is meant for use for the static hypothermic preservation of hearts throughout transportation and eventual transplantation right into a recipient utilizing chilly storage options indicated to be used with the guts. The meant organ storage time for the Paragonix SherpaPak™ Cardiac Transport System is as much as four hours. Donor hearts exceeding clinically accepted static hypothermic preservation instances needs to be evaluated by the transplant surgeon to find out transplantability in accordance with accepted medical pointers and in the very best medical curiosity of the meant recipient.
About Paragonix Applied sciences
Paragonix Technologies designs, produces, and markets organ preservation and transport units that safeguard organs throughout the journey between donor and recipient sufferers. Our award-winning units mitigate danger in an in any other case excessive stakes setting. The Paragonix SherpaPak programs incorporate clinically confirmed and medically trusted chilly preservation strategies in a novel suspension system to supply unprecedented bodily and thermal safety. Paragonix SherpaPak™ CTS is the one commercially obtainable FDA-cleared and CE-marked transport gadget for coronary heart preservation. Paragonix markets the one FDA-cleared and CE-marked hypothermic storage gadget for lungs, the LUNGguard system. Paragonix can be creating transport units for the liver, kidney and pancreas—designed to enhance donor organ high quality and lengthen donor organ preservation time.
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CONTACT: Michael Tajima
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INDUSTRY KEYWORD: SURGERY MEDICAL DEVICES FINANCE HOSPITALS PROFESSIONAL SERVICES CARDIOLOGY BIOTECHNOLOGY HEALTH GENERAL HEALTH
SOURCE: Paragonix Applied sciences
Copyright Enterprise Wire 2021.
PUB: 04/28/2021 07:53 AM/DISC: 04/28/2021 07:53 AM
Copyright Enterprise Wire 2021.
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