United Therapeutics Corporation has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its LungFX device, enabling centralised ex vivo lung perfusion (EVLP) to assess donor lungs outside the body before transplantation.
The approval was granted based on safety and effectiveness data submitted by Lung Bioengineering Inc., a wholly owned subsidiary of United Therapeutics.
The device is designed to evaluate donor lungs that cannot be matched for immediate transplantation through conventional organ procurement procedures.
LungFX provides normothermic perfusion and ventilation to donor lungs after initial cold preservation, allowing clinicians to reassess their suitability for transplantation in a controlled environment.
It is approved for evaluating single and double donor lungs intended for adult patients aged 18 years and older awaiting their first lung transplant.
Following assessment, lungs accepted for transplantation undergo a second period of cold preservation, with total preservation time not exceeding 20 hours.
Lung Bioengineering has performed more than 1,100 EVLP procedures using previously approved systems, resulting in over 600 donor lungs being accepted for transplantation.
The company expects to introduce LungFX into its commercial services in 2027.
The approval expands access to centralised EVLP for transplant programmes and supports United Therapeutics' strategy to improve donor lung utilisation and increase the availability of transplantable organs.
