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.
A recent Consensus Statement from ISHLT on donor heart and lung procurement cites the Paragonix SherpaPak CTS as a new technology to prevent freezing.
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.
Caution: Federal (US) law restricts this device to sale by or an the order of a licensed health care practitioner. Please refer to Instructions for Use for full prescribing information. Cleared indication is for 4 hour use. Patents issued and pending. Data on File.
Heart Connector: Heart is fully suspended and immersed for even cooling in preservation solution. Available for most aortic diameters.
1 of 6Dual Canister: Easy to carry, pressure controlled, leak-proof and rigid to safeguard the heart.
2 of 6Temperature Probe: Continuously measures heart solution temperature during storage and preservation.
3 of 6SherpaCool Ribbons: Consistent storage temperature validated for 40+ hours.
4 of 6Datalogger: Continuously displays temperature during storage and preservation.
5 of 6Bluetooth Data: Real-time Bluetooth® reporting to mobile devices
6 of 6No temperature gradients across donor hearts.
Two rigid sterile canisters plus the SherpaPak shipper provide triple barrier protection of the heart.
Continuously measures and displays temperature during storage and transport.
FDA Cleared and CE Marked Device
Use with any FDA-cleared, effective preservation solution indicated for donor heart.
New Procurement Consensus
New consensus statement from ISHLT calls for strategies to avoid close proximity to ice because of irreversible cellular damage and graft failure.
Paragonix SherpaPak CTS helps users confirm achievement of ISHLT Donor Heart and Lung Procurement Consensus Statement preservation goals:
- Physically & thermally isolate with rigid, sterile container
- Temperature maintenance at above freezing risk point
- Measure and record to confirm correct storage
Conventional Cooler Method & Risk of Cold Injuries
Donor hearts when transported in preservation solutions inside the conventional cooler method risk cold injury at <2°C in less than 30 minutes due to the cooler method having an uncontrolled temperature range. 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
Delivering Life to the Smallest of Patients
Paragonix SherpaPak™ Cardiac Transport System (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.
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