FDA approves first device for centralized ex vivo lung perfusion of donor lungs

The U.S. Food and Drug Administration has granted premarket approval (PMA) to United Therapeutics Corporation's LungFX device for use in centralized ex vivo lung perfusion (EVLP), a procedure that lets clinicians assess donor lungs outside the body after procurement and before transplantation, the company announced.

The PMA was submitted by Lung Bioengineering Inc., a wholly owned subsidiary of United Therapeutics (Nasdaq: UTHR), a public benefit corporation. The application included safety and effectiveness data supporting use of LungFX to perform EVLP in a centralized facility setting, according to the announcement.

LungFX is indicated for centralized, ex vivo evaluation of deceased-donor lungs — both single and double — that an organ procurement organization (OPO) could not place for transplantation using direct-to-recipient procurement and preservation procedures with any matched candidate. The device provides normothermic perfusion and ventilation of donor lungs that were initially stored using cold static preservation solution.

The device is intended to allow re-assessment, in a controlled environment, of whether procured donor lungs are suitable for transplantation into male and female patients age 18 and older with end-stage lung disease who are awaiting a first-time single or double lung transplant. Lungs accepted for transplantation following LungFX evaluation require a second period of cold static storage, and total preservation time for transplanted lungs is not intended to exceed 20 hours, per the announcement.

Lung Bioengineering has performed 1,100 EVLP procedures to date using other approved devices, resulting in 600 lungs accepted for transplant, the company said. It expects to add LungFX to its available services in 2027.

"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," Martine Rothblatt, Ph.D., chairperson and chief executive officer of United Therapeutics, said in the announcement. "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."

Kenneth McCurry, M.D., director of the Cleveland Clinic Enterprise Transplant Center and an investigator in the LungFX pivotal trial, said too many donor lungs go unused today. "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," he said. "Our work with Lung Bioengineering over the last ten years has significantly increased the number of patients we have been able to successfully transplant."

Brandi Zofkie, M.P.H., associate vice president of Lung Bioengineering, said LungFX is the first EVLP device approved specifically for use in a fit-for-purpose centralized facility, which expands access for transplant programs without requiring them to build EVLP capabilities in their own hospitals. "It also strengthens United Therapeutics' platform for advancing new technologies designed to enhance donor lung function," she said.

Lung Bioengineering operates centralized EVLP facilities in Silver Spring, Maryland, and Jacksonville, Florida, where it performs procedures designed to extend preservation time and assess donor lungs that might otherwise be deemed unsuitable for transplant.

The 510(k) clearance and PMA pathways that govern devices like LungFX reflect a tiered, risk-based review system distinct from the multiphase trials required for drugs — a distinction relevant to physicians evaluating how quickly new transplant-support technologies can move from clinical study to bedside use.

The approval also lands amid a broader push to expand the usable donor organ pool across transplant specialties. Discarded or underused organs have been a persistent problem industry-wide, prompting interest in approaches that extend preservation windows or improve real-time assessment of organ viability before transplant. In kidney transplantation, for instance, researchers have explored using organs previously considered marginal — such as those from donors with treatable infections — to shorten wait times and reduce costs, with outcomes data supporting wider acceptance of organs once routinely discarded.

That broader trend toward technology-enabled organ utilization spans multiple solid-organ programs, not just lung transplantation. Ex vivo perfusion systems, in particular, have drawn attention because they allow transplant teams to observe organ function in real time rather than relying solely on donor history and visual inspection at the time of procurement. For physicians managing patients with end-stage organ disease, the practical effect of these technologies is typically measured in waitlist time: any approach that increases the share of procured organs ultimately transplanted has the potential to shorten time to transplant and reduce waitlist mortality, particularly for patients who are sensitized, have rare blood types, or otherwise face longer odds of a match. Centralized service models — in which evaluation occurs at a dedicated facility rather than at each transplant center — also lower the capital and staffing burden for individual hospital programs, potentially expanding access to organ-assessment technology for centers that could not otherwise justify building or maintaining it in house.