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Paragonix Technologies LIVERguard® Used in Cross-Country Donor Liver Transplant Case
Paragonix Technologies LIVERguard® Used in Cross-Country Donor Liver Transplant Case

Business Wire

time13-05-2025

  • Health
  • Business Wire

Paragonix Technologies LIVERguard® Used in Cross-Country Donor Liver Transplant Case

WALTHAM, Mass.--(BUSINESS WIRE)-- Paragonix Technologies, Inc., a leader in organ preservation technology, announces an exciting achievement for its Paragonix LIVERguard® System as the device safely preserved a donor liver during a recovery which covered the cross-country distance from the West Coast to North Carolina. This incredible journey resulted in a successful transplant at Duke University Hospital, one of the largest organ transplant centers in the world. The case marks one of the longest liver procurements on record utilizing advanced hypothermic preservation and highlights the potential of this technology to procure more donor livers at greater distances, potentially enabling more life-saving transplants. Duke University Hospital received a donor match on the West Coast for a patient on its waitlist. Historically, due to the organ's distance from the hospital, the team would have to seriously consider the impact of out of body time (cold ischemic time) of the organ for the recipient. As an early adopter of advanced hypothermic liver preservation technology, the transplant team felt confident that the technology would successfully preserve the organ in an optimal condition. This long-distance transplant case demonstrates the impact of advanced preservation technology on increasing access to donor organs, with this donor liver traveling over 2,000 nautical miles. 'Traditionally, geographical distance has played a crucial role in assessing donor organ suitability. The advent of innovative technologies such as advanced liver preservation now enables transplant centers to broaden their access to donor organs, facilitating better matches between recipients and available organs,' stated Dr. Andrew Barbas, Associate Professor of Surgery at Duke University Hospital. More than 106,000 patients are currently on the national transplant waitlist in the U.S. making expanding donor pools and optimizing available resources critical. Controlled hypothermic preservation has shown significant benefits for liver transplants. The LIVERguard system's compact and easy-to-transport design combines stable cooling technology driven by real-time data monitoring, ensuring donor livers arrive in optimal condition and improving the process from donation to recipient. 'We are committed to honoring both the donor and recipient throughout the organ transplantation process," said Dr. Lisa Anderson, President of Paragonix Technologies. "By leveraging advanced technologies like LIVERguard, surgeons can now offer organs to patients that were previously inaccessible due to distance or prolonged ischemic time. This capability ensures the donor's gift is respected, allowing for optimal matches with recipients who are most in need.' For more information about Paragonix, visit About Paragonix Technologies Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. A Getinge company, Paragonix Technologies provides Advanced Organ Preservation ('AOP') devices that safeguard donor organs during the journey between donor and recipient patients. Their FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with a novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit About Getinge With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile processing and life science. Getinge employs approximately 12,000 people worldwide and the products are sold in more than 135 countries.

New Study Reports Increased 4-Year Survival in Heart Transplant Patients when Utilizing the Paragonix SherpaPak System
New Study Reports Increased 4-Year Survival in Heart Transplant Patients when Utilizing the Paragonix SherpaPak System

Business Wire

time29-04-2025

  • Health
  • Business Wire

New Study Reports Increased 4-Year Survival in Heart Transplant Patients when Utilizing the Paragonix SherpaPak System

WALTHAM, Mass.--(BUSINESS WIRE)-- Paragonix Technologies, a leader in organ transplant technologies and organ procurement services, announces new research presented during the 45 th ISHLT Annual Meeting and Scientific Sessions. The expansive study compared long-term outcomes of donor hearts preserved with the Paragonix SherpaPak ® Cardiac Transport System, an FDA-cleared and CE-marked device, to those stored on conventional ice storage over four years post transplantation. Drawing on data from the GUARDIAN-Heart Registry, the study compared four-year mortality rates between the SherpaPak System and ice storage in US adult heart transplant recipients. In a propensity-matched analysis, researchers found a 54% reduction in 4-year mortality (p =0.018), and an improvement in survival at each yearly interval compared to historical ice storage. 1 72% Reduction in 1 Year Mortality (Ice – 23/243 (9.5%) vs SherpaPak - 2/243 (2.7%), p=0.003) 1 68% Reduction in 2 Year Mortality (Ice – 32/241 (13.3%) vs SherpaPak - 9/213 (4.2%), p<0.001) 1 52% Reduction in 3 Year Mortality (Ice – 39/235 (16.6%) vs SherpaPak - 13/165 (7.9%), p=0.010) 1 54% Reduction in 4 Year Mortality (Ice – 39/177 (22.0%) vs SherpaPak - 9/88 (10.2%), p=0.018) 1 Additionally, researchers found that hearts transported with a SherpaPak System had a 50% reduction in severe primary graft dysfunction (PGD) (p=0.017) and a 63% reduction in severe right ventricular dysfunction (RVD) (p=0.007). The study concluded that the utilization of the SherpaPak System for organ preservation was associated with improved post-transplant outcomes, including a statistically significant survival advantage over four years. 1 Researchers presented additional findings from the GUARDIAN-Heart Registry at the conference, which concluded: Compared to conventional ice storage, use of the SherpaPak System was linked to a lower development of cardiac allograft vasculopathy (CAV), one of the most common late-term morbidities in heart transplant. Researchers presented data that found that patients in the SherpaPak cohort had significantly lower rates of any CAV in years three and four, with year four exhibiting 17.7% (SherpaPak) vs. 23.6% (Ice) (p =0.047). 2 In an analysis of Global Adult Extended Criteria Donors, the SherpaPak System was associated with a reduction in post-transplant clinical complications, including a 26% reduction in post-transplant mechanical circulatory support (0.043), a 31% reduction in PGD (p=0.020), and a 61% reduction in severe RVD (p<0.001). 3 A study on rehospitalizations in the first year after heart transplantation found a significant increase in freedom from all-cause rehospitalization (p=0.003), including cardiovascular-related rehospitalizations (p=0.017) using the SherpaPak System in comparison to ice storage. 4 'Our research indicates that the use of moderate, controlled hypothermia not only significantly reduced the risk of Severe PGD and severe RVD, but also significantly reduced mortality through 4 years post-transplant,' said Dr. David D'Alessandro, Director of Heart Transplantation and Ventricular Assist Devices at Massachusetts General Hospital. "These landmark findings represent monumental progress in heart transplantation technology and research. The GUARDIAN Registry research data clearly demonstrates that patients whose donor hearts were preserved with the Paragonix SherpaPak experience a statistically significant improvement in outcomes,' said Lisa Anderson, Ph.D., President of Paragonix Technologies. 'At Paragonix, we remain committed to working alongside the transplant community to ensure every donor gift has the greatest chance to save and sustain life." Paragonix is committed to working closely with transplant centers, organ procurement organizations, and healthcare professionals to ensure broad accessibility of its Advanced Organ Preservation technology, including the SherpaPak System, which is utilized across over 130 programs globally to preserve and protect donor hearts. For more information about Paragonix Advanced Organ Preservation devices, please visit About Paragonix Technologies Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. A Getinge company, Paragonix Technologies provides Advanced Organ Preservation ('AOP') devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit About Getinge With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile processing and life science. Getinge employs approximately 12,000 people worldwide and the products are sold in more than 135 countries. Connect with us on LinkedIn: Paragonix Technologies Follow us on X (formerly twitter): @ParagonixSherpa Find us on YouTube: Paragonix SherpaPak References D'Alessandro et al., 2025 ISHLT Presentation 2025, Data on File Uriel et al., 2025 ISHLT Presentation 2025, Data on File Moayedifar et al., 2025 ISHLT Presentation 2025, Data on File Khush et al. 2025 ISHLT Presentation 2025, Data on File Disclaimer Comparison of Paragonix systems to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study funded and administered by Paragonix Technologies. The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.

New Study Reports Increased 4-Year Survival in Heart Transplant Patients when Utilizing the Paragonix SherpaPak System
New Study Reports Increased 4-Year Survival in Heart Transplant Patients when Utilizing the Paragonix SherpaPak System

Yahoo

time29-04-2025

  • Health
  • Yahoo

New Study Reports Increased 4-Year Survival in Heart Transplant Patients when Utilizing the Paragonix SherpaPak System

Data from the GUARDIAN Registry, presented at the 45th ISHLT Annual Meeting, shows the Paragonix SherpaPak® Cardiac Transport System led to statistically significant improvements in short and long-term post-transplant survival and cardiac complications WALTHAM, Mass., April 29, 2025--(BUSINESS WIRE)--Paragonix Technologies, a leader in organ transplant technologies and organ procurement services, announces new research presented during the 45th ISHLT Annual Meeting and Scientific Sessions. The expansive study compared long-term outcomes of donor hearts preserved with the Paragonix SherpaPak® Cardiac Transport System, an FDA-cleared and CE-marked device, to those stored on conventional ice storage over four years post transplantation. Drawing on data from the GUARDIAN-Heart Registry, the study compared four-year mortality rates between the SherpaPak System and ice storage in US adult heart transplant recipients. In a propensity-matched analysis, researchers found a 54% reduction in 4-year mortality (p=0.018), and an improvement in survival at each yearly interval compared to historical ice storage.1 72% Reduction in 1 Year Mortality (Ice – 23/243 (9.5%) vs SherpaPak - 2/243 (2.7%), p=0.003) 1 68% Reduction in 2 Year Mortality (Ice – 32/241 (13.3%) vs SherpaPak - 9/213 (4.2%), p<0.001) 1 52% Reduction in 3 Year Mortality (Ice – 39/235 (16.6%) vs SherpaPak - 13/165 (7.9%), p=0.010) 1 54% Reduction in 4 Year Mortality (Ice – 39/177 (22.0%) vs SherpaPak - 9/88 (10.2%), p=0.018) 1 Additionally, researchers found that hearts transported with a SherpaPak System had a 50% reduction in severe primary graft dysfunction (PGD) (p=0.017) and a 63% reduction in severe right ventricular dysfunction (RVD) (p=0.007). The study concluded that the utilization of the SherpaPak System for organ preservation was associated with improved post-transplant outcomes, including a statistically significant survival advantage over four years. 1 Researchers presented additional findings from the GUARDIAN-Heart Registry at the conference, which concluded: Compared to conventional ice storage, use of the SherpaPak System was linked to a lower development of cardiac allograft vasculopathy (CAV), one of the most common late-term morbidities in heart transplant. Researchers presented data that found that patients in the SherpaPak cohort had significantly lower rates of any CAV in years three and four, with year four exhibiting 17.7% (SherpaPak) vs. 23.6% (Ice) (p=0.047).2 In an analysis of Global Adult Extended Criteria Donors, the SherpaPak System was associated with a reduction in post-transplant clinical complications, including a 26% reduction in post-transplant mechanical circulatory support (0.043), a 31% reduction in PGD (p=0.020), and a 61% reduction in severe RVD (p<0.001). 3 A study on rehospitalizations in the first year after heart transplantation found a significant increase in freedom from all-cause rehospitalization (p=0.003), including cardiovascular-related rehospitalizations (p=0.017) using the SherpaPak System in comparison to ice storage. 4 "Our research indicates that the use of moderate, controlled hypothermia not only significantly reduced the risk of Severe PGD and severe RVD, but also significantly reduced mortality through 4 years post-transplant," said Dr. David D'Alessandro, Director of Heart Transplantation and Ventricular Assist Devices at Massachusetts General Hospital. "These landmark findings represent monumental progress in heart transplantation technology and research. The GUARDIAN Registry research data clearly demonstrates that patients whose donor hearts were preserved with the Paragonix SherpaPak experience a statistically significant improvement in outcomes," said Lisa Anderson, Ph.D., President of Paragonix Technologies. "At Paragonix, we remain committed to working alongside the transplant community to ensure every donor gift has the greatest chance to save and sustain life." Paragonix is committed to working closely with transplant centers, organ procurement organizations, and healthcare professionals to ensure broad accessibility of its Advanced Organ Preservation technology, including the SherpaPak System, which is utilized across over 130 programs globally to preserve and protect donor hearts. For more information about Paragonix Advanced Organ Preservation devices, please visit About Paragonix Technologies Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. A Getinge company, Paragonix Technologies provides Advanced Organ Preservation ("AOP") devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit About Getinge With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile processing and life science. Getinge employs approximately 12,000 people worldwide and the products are sold in more than 135 countries. Connect with us on LinkedIn: Paragonix Technologies Follow us on X (formerly twitter): @ParagonixSherpa Find us on YouTube: Paragonix SherpaPak References D'Alessandro et al., 2025 ISHLT Presentation 2025, Data on File Uriel et al., 2025 ISHLT Presentation 2025, Data on File Moayedifar et al., 2025 ISHLT Presentation 2025, Data on File Khush et al. 2025 ISHLT Presentation 2025, Data on File Disclaimer Comparison of Paragonix systems to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study funded and administered by Paragonix Technologies. The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly. View source version on Contacts Media Contact:Adam LafreniereVice President, Marketingmarketing@

Paragonix Celebrates 100th Kidney Transplant Case with FDA-Cleared KidneyVault™ System
Paragonix Celebrates 100th Kidney Transplant Case with FDA-Cleared KidneyVault™ System

Yahoo

time21-04-2025

  • Business
  • Yahoo

Paragonix Celebrates 100th Kidney Transplant Case with FDA-Cleared KidneyVault™ System

Tennessee Donor Services utilizes Paragonix KidneyVault™ Renal Perfusion System in milestone case. WALTHAM, Mass., April 21, 2025--(BUSINESS WIRE)--Paragonix Technologies, a leader in organ transplant technologies and services, today announced the successful completion of its hundredth case using the FDA-cleared KidneyVault™ Portable Renal Perfusion System. This milestone was achieved with the support of Tennessee Donor Services (TDS), an Organ Procurement Organization (OPO) that serves more than 6 million people across Tennessee and Virginia. In recent years, the transplantation industry has removed geographic barriers to ensure organs may reach those in greatest need, meaning organs now travel farther and remain outside the body longer. For kidney transport, the gold standard of preservation is hypothermic machine perfusion - a clinically accepted therapy that continuously pumps a specialized solution through the organ. The KidneyVault System is the first hypothermic machine perfusion device specifically designed to maximize mobility. The device offers a comprehensive, portable solution from end-to-end, allowing transplant teams to continuously perfuse the kidney and monitor key perfusion metrics in real-time through a mobile-friendly, data-driven dashboard. The innovative system was first used shortly after achieving FDA clearance in late 2024 and has been rapidly adopted by likeminded organizations across the nation ever since. Now, over 12 OPOs stock the device, and 100 donor kidneys have been placed in a KidneyVault for transplant. This rapid adoption reflects a broader shift in the field — one that embraces new technology to meet the evolving demands of organ recovery and allocation. "Tennessee Donor Services' mission is to save and improve lives through organ, eye, and tissue donation, and we're proud of our teams who embrace innovation to save as many lives as possible. It's exciting to partner with Paragonix to be an early adopter of the KidneyVault, a technology that will help more people get their lifesaving transplant, and work alongside their teams to make donation and transplant possible," said Jill Grandas, CEO of Tennessee Donor Services. Leading OPOs like Tennessee Donor Services are leveraging the KidneyVault System to expand access to the limited supply of donor organs and improve post-transplant outcomes. As of April 2025, nearly 90,700 people are on the kidney transplant waiting list in the U.S., representing 86% of the national transplant list. In 2024, 27,761 kidney transplants were performed, highlighting the urgent need for innovative solutions to address the organ shortage. "This hundredth KidneyVault case is a significant milestone for Paragonix and underscores our company's commitment to enhancing the future of organ transplantation," said Dr. Lisa Anderson, President of Paragonix Technologies. "We are proud to offer advanced preservation technologies across all solid organ transplants, and our ability to provide a truly portable renal perfusion system aligns with our mission to provide 'Every Possible Advantage' to those waiting for lifesaving transplants." For more information about Paragonix Technologies, please visit About Tennessee Donor Services An Extraordinary Commitment to Science, Health, and Hope Tennessee Donor Services is a non-profit, organ procurement organization (OPO) dedicated to saving and improving lives by connecting organ and tissue donations to the patients who need them. TDS serves more than six million people in Tennessee and Virginia. About Paragonix Technologies Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. A Getinge company, Paragonix Technologies provides Advanced Organ Preservation ("AOP") devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit Connect with us on LinkedIn: Paragonix Technologies Follow us on Twitter: @ParagonixSherpa Like Us on Facebook: Paragonix SherpaPak View source version on Contacts Media: Adam LafreniereVice President, Marketingmarketing@

Paragonix Celebrates 100 th Kidney Transplant Case with FDA-Cleared KidneyVault™ System
Paragonix Celebrates 100 th Kidney Transplant Case with FDA-Cleared KidneyVault™ System

Business Wire

time21-04-2025

  • Health
  • Business Wire

Paragonix Celebrates 100 th Kidney Transplant Case with FDA-Cleared KidneyVault™ System

WALTHAM, Mass.--(BUSINESS WIRE)-- Paragonix Technologies, a leader in organ transplant technologies and services, today announced the successful completion of its hundredth case using the FDA-cleared KidneyVault™ Portable Renal Perfusion System. This milestone was achieved with the support of Tennessee Donor Services (TDS), an Organ Procurement Organization (OPO) that serves more than 6 million people across Tennessee and Virginia. In recent years, the transplantation industry has removed geographic barriers to ensure organs may reach those in greatest need, meaning organs now travel farther and remain outside the body longer. For kidney transport, the gold standard of preservation is hypothermic machine perfusion - a clinically accepted therapy that continuously pumps a specialized solution through the organ. The KidneyVault System is the first hypothermic machine perfusion device specifically designed to maximize mobility. The device offers a comprehensive, portable solution from end-to-end, allowing transplant teams to continuously perfuse the kidney and monitor key perfusion metrics in real-time through a mobile-friendly, data-driven dashboard. The innovative system was first used shortly after achieving FDA clearance in late 2024 and has been rapidly adopted by likeminded organizations across the nation ever since. Now, over 12 OPOs stock the device, and 100 donor kidneys have been placed in a KidneyVault for transplant. This rapid adoption reflects a broader shift in the field — one that embraces new technology to meet the evolving demands of organ recovery and allocation. 'Tennessee Donor Services' mission is to save and improve lives through organ, eye, and tissue donation, and we're proud of our teams who embrace innovation to save as many lives as possible. It's exciting to partner with Paragonix to be an early adopter of the KidneyVault, a technology that will help more people get their lifesaving transplant, and work alongside their teams to make donation and transplant possible,' said Jill Grandas, CEO of Tennessee Donor Services. Leading OPOs like Tennessee Donor Services are leveraging the KidneyVault System to expand access to the limited supply of donor organs and improve post-transplant outcomes. As of April 2025, nearly 90,700 people are on the kidney transplant waiting list in the U.S., representing 86% of the national transplant list. In 2024, 27,761 kidney transplants were performed, highlighting the urgent need for innovative solutions to address the organ shortage. "This hundredth KidneyVault case is a significant milestone for Paragonix and underscores our company's commitment to enhancing the future of organ transplantation," said Dr. Lisa Anderson, President of Paragonix Technologies. 'We are proud to offer advanced preservation technologies across all solid organ transplants, and our ability to provide a truly portable renal perfusion system aligns with our mission to provide ' Every Possible Advantage' to those waiting for lifesaving transplants.' For more information about Paragonix Technologies, please visit About Tennessee Donor Services An Extraordinary Commitment to Science, Health, and Hope Tennessee Donor Services is a non-profit, organ procurement organization (OPO) dedicated to saving and improving lives by connecting organ and tissue donations to the patients who need them. TDS serves more than six million people in Tennessee and Virginia. About Paragonix Technologies Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. A Getinge company, Paragonix Technologies provides Advanced Organ Preservation ('AOP') devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit

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