United Therapeutics announced that the US Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for its LungFX perfusion device. The system, which received regulatory clearance through United Therapeutics’ wholly owned subsidiary, Lung Bioengineering Inc., is explicitly designed for ex vivo lung perfusion (EVLP). This specialized procedure allows deceased-donor organs to be thoroughly evaluated outside the human body after procurement and prior to transplantation.
The LungFX system works by providing normothermic (normal body temperature) perfusion and ventilation to donor lungs that have initially been preserved using a standard cold static solution. The technology is specifically indicated for adult patients with end-stage lung disease awaiting their first single or double lung transplant. It acts as a controlled testing environment to re-evaluate marginal or complex lungs that otherwise could not be successfully matched or placed through standard, direct-to-recipient organ procurement avenues.
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Operationally, lungs that are deemed viable for transplantation after undergoing the LungFX process are placed back into cold static storage before being surgically implanted. The FDA approval mandates that the cumulative preservation time for these transplanted organs must not exceed 20 hours. Crucially, LungFX is engineered as the first EVLP system approved specifically for use within a “fit-for-purpose” centralized facility rather than requiring individual hospitals to house and maintain the highly resource-intensive equipment.
“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.”
