Device Dossier

PERFADEX Plus - Organ preservation solution

Device Dossier for PERFADEX Plus - Organ preservation solution (Organ preservation solution, Class III, sponsor Emergo). ARTG record, intended purpose,…

Intended purpose

PERFADEX Plus is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Functional description

PERFADEX Plus is an extracellular electrolyte solution containing Dextran 40. The device is used for rapid cooling, perfusion and cold static storage of lungs in connection with transplantation. The device enables safe preservation of lungs for up to 12 hours depending of status of the lung during retrieval. The intended patient population is adult patients in need of a lung transplantation.

TGA Public Summary