United Therapeutics Corporation has received U.S. Food and Drug Administration (FDA) premarket approval for the LungFX device, the first technology authorized for centralized ex vivo lung perfusion (EVLP). This approval enables the assessment of donor lungs outside the body before transplantation, specifically targeting organs that cannot be placed for transplant through standard direct-to-recipient procurement procedures. The device is intended to reduce the high percentage of donor lungs that are currently discarded rather than used.

The premarket approval was submitted by Lung Bioengineering Inc., a wholly owned subsidiary of United Therapeutics. The submission included comprehensive safety and effectiveness data supporting the use of LungFX to perform EVLP in a centralized facility. LungFX provides normothermic perfusion and ventilation of procured donor lungs that were initially stored with cold static preservation solution. It is indicated for the re-assessment of deceased-donor lungs for male and female patients aged 18 years or older with end-stage lung disease. Under the approved labeling, lungs transplanted following LungFX evaluation must undergo a second period of cold storage, with total preservation time not intended to exceed 20 hours.

Operational Details and Safety

Lung Bioengineering has performed 1,100 EVLP procedures using other approved devices to date, with 600 lungs accepted for transplant. The company expects to integrate LungFX into its available services in 2027. The device is designed to allow transplant programs to access EVLP capabilities without building them within their own hospitals, as only qualified Lung Bioengineering personnel can operate the device and only trained physicians can evaluate lung suitability after the procedure.

The FDA approval includes specific warnings regarding clinical outcomes. In the CLES Pivotal Study, the observed 12-month survival rate among recipients of LungFX lungs did not meet the pre-specified performance goal. Rates of 12-month overall mortality and lung graft-related mortality were higher in EVLP subjects compared to non-EVLP control subjects. Consequently, physicians are advised to fully consider the risks and benefits before proceeding with LungFX organ preservation.

Strategic Implications

Martine Rothblatt, Chairperson and Chief Executive Officer of United Therapeutics, emphasized that the approval is a significant step toward reducing the number of donor lungs left behind. The company views this as a milestone in its path toward using advanced technologies to create an unlimited supply of transplantable organs. Dr. Kenneth McCurry, director of the Cleveland Clinic Enterprise Transplant Center and an investigator in the LungFX pivotal trial, noted that the technology provides transplant teams with additional clinical information to determine donor lung suitability. Brandi Zofkie, associate vice president of Lung Bioengineering, highlighted that LungFX is the first EVLP device approved specifically for centralized facilities. Lung Bioengineering operates centralized EVLP facilities in Silver Spring, Maryland, and Jacksonville, Florida.