The company designed LungFX for use in ex vivo lung perfusion (EVLP). This procedure enables the assessment of donor lungs outside the body after procurement and before transplantation. United Therapeutics’ wholly owned Lung Bioengineering subsidiary received the PMA for LungFX.
LungFX provides normothermic perfusion and ventilation of procured donor lungs initially stored with cold static preservation solution. United Therapeutics intends for the system to reassess the suitability of donor lungs in controlled environments 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. Lungs accepted for transplantation after LungFX require a second period of storage with cold static preservation solution. Cumulative preservation time of transplanted lungs is not intended to exceed 20 hours.
“Today’s approval is a big step forward in reducing the large number of donor lungs — over 80% — that are unfortunately left behind instead of being transplanted,” said Martine Rothblatt, chair and CEO of United Therapeutics. “The FDA approval of our LungFX device also marks an important milestone on our path toward using advanced technologies to create an unlimited supply of transplantable organs.”
Other noteworthy perfusion systems include Xvivo’s system, which received FDA approval in 2019. LivaNova also offers a heart-lung perfusion system that addresses cardiopulmonary bypass.
TransMedics and Paragonix also develop technologies in the same area, preserving donor lungs ahead of transplantation.
