United Therapeutics Corporation announced that the U.S. Food and Drug Administration has granted premarket approval of the LungFX device for centralized ex vivo lung perfusion. LungFX is the first device approved for centralized ex vivo lung perfusion, enabling assessment of deceased-donor lungs that cannot be placed for transplantation by an organ procurement organization using standard procedures. The device provides normothermic perfusion and ventilation of procured donor lungs initially stored with cold static preservation solution, allowing re-assessment of suitability for transplant in patients aged 18 or older with end-stage lung disease. United Therapeutics' subsidiary Lung Bioengineering has performed 1,100 ex vivo lung perfusion procedures using other approved devices, with 600 lungs accepted for transplant, and expects to add LungFX to its services in 2027. The approval marks a step toward reducing the over 80% of donor lungs that go unused, according to the company.
United Therapeutics CorporationFDA approval of LungFX device for centralized ex vivo lung perfusion.
Subsidiary Lung Bioengineering will add LungFX to its services in 2027.