United Therapeutics has been given a premarket approval (PMA) from the FDA for its LungFX device.
The product can now be used in centralized ex vivo lung perfusion (EVLP). This allows lungs that have been donated for transplant to be looked at and assessed outside the body before being transplanted.
This could allow for more donated lungs to be used for transplantation by having their viability for specific patients matched up.
Specifically under the PMA, LungFX “is intended to allow for re-assessment, in a controlled environment, of the suitability of procured donor lungs 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,” United said in a statement.
The tech comes out of United’s Lung Bioengineering subsidiary, and the company said it “expects to add LungFX to its available services in 2027.”
“Too many donor lungs go unused today,” Dr. Kenneth McCurry, M.D., Director of the Cleveland Clinic Enterprise Transplant Center and investigator in the LungFX pivotal trial, said in the release.
“EVLP with this device provides additional clinical data to transplant teams to help determine whether donated lungs that might otherwise go unused are suitable for transplant.”