United Therapeutics announced that the U.S. Food and Drug Administration has granted premarket approval of the LungFX device for centralized ex vivo lung perfusion.
The device is indicated for centralized evaluation of deceased-donor single and double lungs that cannot be placed for transplantation by an organ procurement organization using direct-to-recipient procedures and provides normothermic perfusion and ventilation of procured lungs initially stored with cold static preservation solution.
LungFX is intended to reassess suitability for transplantation in adults aged 18 years or older awaiting first-time lung transplant; lungs accepted after LungFX require a second period of cold static preservation and cumulative preservation time is not intended to exceed 20 hours.
The company reports that Lung Bioengineering has performed 1,100 EVLP procedures using other approved devices, with 600 lungs accepted for transplant and expects to add LungFX to its services in 2027.
The release includes safety information noting no known contraindications but states that the pivotal CLES study did not meet a pre-specified 12-month survival performance goal and observed higher 12-month overall and graft-related mortality in EVLP subjects versus non-EVLP controls; the company notes long-term effects on recipient survival and graft function are uncertain and that only qualified personnel should operate and evaluate lungs with the device.
