Important Safety Information

Paragonix SherpaPak®

Indications for Use

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:
1. 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 LUNGguard™

Indications for Use

The Paragonix LUNGguard™ (LUNGguard™) is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.

The intended organ storage time for LUNGguard™ is up to 8 hours.

Donor lungs 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.

Note: Partial lungs can be transported via LUNGguard™ by packaging lungs per institutional protocol and UNOS guidelines.