The Paragonix 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.
Please review the instructions for use for complete prescribing information including indications, contraindications, warnings and precautions.
The intended organ storage time for the Paragonix 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.
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. Partial lungs can be transported via Paragonix LUNGguard by packaging lungs per institutional protocol and UNOS guidelines. Donor lungs exceeding 8 hours static hypothermic preservation time will require transplant surgeon evaluation to determine transplantability. Patents issued and pending. Data on File.
No temperature gradients across donor lung.
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 lung.