CARDIAC Transport System
The Paragonix SherpaPak™ Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the Paragonix SherpaPak™ Cardiac Transport System is up to 4 hours.
Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.
Please review the instructions for use for complete prescribing information including indications, contraindications, warnings and precautions.
1 Patents issued and pending.
2 Caution: Federal (US) law restricts this device to sale by or an the order of a licensed health care practitioner.
3 Please refer to Instructions for Use for full prescribing information.
4 Cleared indication is for 4 hour use. Data on File.
Controlled Temperature Range
No temperature gradients across donor hearts
Suspended & Immersed in Preservation Solution
Two rigid sterile canisters plus the Paragonix SherpaPak™ shipper provide triple barrier protection of organ
Real-time Data Reporting & Monitoring
Continuously measures and displays temperature during storage and transport
FDA Cleared & CE Marked Device
Use with any FDA-cleared, effective preservation solution indicated for donor hearts
2018-2019 US & Europe CTS Experience
Paragonix SherpaPak™ transport time (min)
Total Ischemic Time (min)
% of transports >2 hours total ischemic time
% of transports >4 hours
Paragonix SherpaPak™ Internal Temp (C°)
# of Adverse Failures & Device Failures
Risk of Cold Injuries
Time it takes donor hearts that are transported using the conventional cooler method to risk cold injury at <2°C. 1-5
Temperature range of 3 available preservation solutions according to their labeling should be at 2-8° C or 2-6° C.8-10
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.
Delivering Life to the Smallest of Patients
Paragonix SherpaPak™ CTS, is now cleared by the FDA to be used with small and pediatric donor hearts.
Heart connectors covering most aortic diameters, are provided with the Paragonix SherpaPak™ Cardiac Transport System, permitting the anchoring of various size hearts.
"Heart transplantation has been around for over 50 years now....[and] it’s time to be a little more scientific about how we do this. "
"Definitely a game-changer. The hearts are different when they come back. They are soft, not frozen, not stiff."
"The first beat is like a hammer being dropped. "
"I believe that the SherpaPak™ Cardiac Transport System addresses the shortcomings of current cold storage by improving temperature maintenance and monitoring of the donor heart during transport. "
"With the ice box, sometimes we have hearts with frostbite."
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