DURHAM, N.C.--(BUSINESS WIRE)--Duke University Hospital has transported its first donor heart using the only commercially available FDA cleared and CE marked system for cold donor heart storage and transport. The Paragonix SherpaPak™ Cardiac Transport System (CTS) was used in a clinical case to safeguard a donor heart prior to it being transplanted into an adult recipient, who is recovering well.
Preservation of donor organs is critical for maintaining viability during the journey from donor to recipient. The current standard for transporting a donor organ, such as a heart, includes storage in preservation solution within sequential plastic bags that are placed inside a standard cooler containing slush ice. With this storage method, there is potential for the temperature of the donor organ to drop too low, a situation that could lead to tissue injury, temperature gradients across the organ and lack of pressure maintenance during transport.
Studies show that it can take less than 30 minutes for a donor heart that is transported using the conventional cooler method to risk cold injury at <2°C. 1-51 The Paragonix SherpaPak™ CTS incorporates clinically proven cold preservation techniques in a novel suspension system that provides unprecedented physical and thermal protection, keeping organs at a stable temperature of 4 to 8°C.
Jacob Niall Schroder, MD, who performed the procedure and serves as surgical director of Duke’s Heart Transplant Program at the Department of Surgery, commented, “We are constantly seeking advances in medical technology beneficial to our heart failure patient population requiring cardiac transplantation. The Paragonix SherpaPak™ Cardiac Transport System is an excellent example of innovation in the demanding field of cardiac transplantation, offering our patients every possible advantage in donor heart recovery, transport and delivery to maximize positive surgical outcomes. Our experience with the Paragonix SherpaPak™ Cardiac Transport System is exciting and we look forward to adding this technology to our practice.”
“We are thrilled to partner with Dr. Schroder and Duke as we continue to bring the Paragonix SherpaPak™ CTS to the heart transplant clinical community in both the US and Europe,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “2019 has demonstrated with increasing confidence the strong market support we are seeing in adopting the Paragonix SherpaPak™ CTS in standard and complex heart transplant scenarios. We look forward to the new year as we continue to build upon the impressive clinical outcomes already reported and the impact the system has made among the heart transplant community.”
About Duke University Hospital
Duke University Hospital is a 957-acute care bed academic tertiary care facility located in Durham, North Carolina. Since its establishment in 1930, the hospital has grown from a small regional hospital to a world-renowned academic medical center. Duke University Medical Center is the group of patient care, education and medical research facilities on the medical campus of Duke University in Durham, NC. The Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Established in 1925 by James B. Duke, the School of Medicine has earned its reputation as an integral part of one of the world's foremost patient care and biomedical research institutions.
About Paragonix Technologies, Inc.
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. Paragonix is also developing transport devices for the lung, liver, pancreas and kidneys designed to improve donor organ quality and extending donor organ transport time.
1 Michel et al., Heart, Lung, and Vessels 2015; 7(3):246-255. 2. Ingemansson et al., Ann Thorac Surg. 1996; 61; 1413-7. 3. Mankad et al., J Thorac Cardiovasc Surg 1992; 104: 1618-1624. 4. Keon et al. Ann Thorac Surg 1988; 46:337-341. 5. Paragonix, Data on file. 6. Letter on file from manufacturer of Custodial HTK, Essential Pharmaceuticals, from Deputy Head of Quality Assurance, April 17, 2019. 7. Tullius et al., Am J Transpl 2002; 2: 627–630. Note: The organ in this study is a kidney. 8. Custodial HTK Solution Prescribing Information. 9. Celsior Package Leaflet. DCP4 REV03, 8/31/2018. 10. Belzer UW® Cold Storage Solution Instructions for Use. RM/N 4107 Rev. 060816.