The company designed LungFX for use in ex vivo lung perfusion (EVLP). This procedure enables the assessment of donor lungs outside the body after procurement and before transplantation. United Therapeutics’ wholly owned Lung Bioengineering subsidiary received the PMA for LungFX.

LungFX provides normothermic perfusion and ventilation of procured donor lungs initially stored with cold static preservation solution. United Therapeutics intends for the system to reassess the suitability of donor lungs in controlled environments for transplantation into male and female patients aged 18 years or older with end-stage lung disease awaiting first-time (double or single) lung transplantation. Lungs accepted for transplantation after LungFX require a second period of storage with cold static preservation solution. Cumulative preservation time of transplanted lungs is not intended to exceed 20 hours.