Paragonix SherpaPak
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.

Asset 13

Controlled Temperature Range

No temperature gradients across donor hearts

Asset 12

Suspended & Immersed in Preservation Solution

Two rigid sterile canisters plus the Paragonix SherpaPak™ shipper provide triple barrier protection of organ

CONNECT

Real-time Data Reporting & Monitoring

Continuously measures and displays temperature during storage and transport​​​

SHIELD RED

FDA Cleared & CE Marked Device

Use with any FDA-cleared, effective preservation solution indicated for donor hearts

Clinical Experience

2018-2019 US & Europe CTS Experience
Paragonix SherpaPak™ transport time (min)
Mean: 132
Min: 7
Max: 279
Total Ischemic Time (min)
Mean: 236
Min: 87
Max: 420
% of transports >2 hours total ischemic time
60%
% of transports >4 hours
40%
Paragonix SherpaPak™ Internal Temp (C°)
Mean: 5.37
Min: 4.40
Max: 6.12
# of Adverse Failures & Device Failures
0

Risk of Cold Injuries

< 0
Minutes

Time it takes donor hearts that are transported using the conventional cooler method to risk cold injury at <2°C. 1-5

2 0 °
Temperature C°

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.

frostbite heart

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.

circle pediatric heart

Clinical Experience

"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. "

Dr. David D’Alessandro Cardiothoracic Surgeon
Massachusetts General Hospital
ISHLT Annual Meeting, April 4, 2019

"Definitely a game-changer. The hearts are different when they come back. They are soft, not frozen, not stiff."

Dr. Jonathan Philpott Cardiothoracic Surgeon
Sentara Hospital
ISHLT Annual Meeting, April 4, 2019

"The first beat is like a hammer being dropped. "

Dr. Jonathan Philpott Cardiothoracic Surgeon
Sentara Hospital
ISHLT Annual Meeting, April 4, 2019

"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. "

Dr. Steven Tsui Clinical Director Transplant Service
Royal Papworth Hospital
Business News Wire, February 20, 2018

"With the ice box, sometimes we have hearts with frostbite."

Dr. Andreas Zuckermann Cardiothoracic Surgeon
Vienna General Hospital
ISHLT Annual Meeting, April 4, 2019