Indications for Use
IFU Version 7 effective January 31, 2025
Mulitlanguage IFU Version 2 effective August 30, 2024
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.
Contraindications
The Paragonix SherpaPak Cardiac Transport System should not be used in the following circumstances:
- When safe connection with the aorta cannot be made, e.g., due to lack of enough length of the aortic root.
Caution: Donor hearts exceeding 4 hours static hypothermic preservation time will require transplant surgeon evaluation to determine transplantability.
*Paragonix SherpaPak Multilanguage IFU is available in English, Spanish, French, Italian, Norwegian, German, Danish, Dutch, and Slovak