FDA OKs United Therapeutics’ Lung Perfusion Device

United Therapeutics Corporation has received U.S. Food and Drug Administration premarket approval (PMA) for its LungFX device for use in centralized ex vivo lung perfusion (EVLP), a procedure that allows donor lungs to be evaluated outside the body after procurement and before transplantation.

LungFX is indicated for centralized, ex vivo evaluation of deceased-donor lungs that cannot be placed for transplantation through standard direct-to-recipient procurement. The system provides normothermic perfusion and ventilation of donor lungs following initial cold static preservation.

It’s intended to enable controlled re-assessment of donor lung suitability for first-time single or double lung transplantation in adults with end-stage lung disease. Transplanted lungs require a second period of cold static preservation, with total preservation time not to exceed 20 hours.

To date, Lung Bioengineering (a subsidiary of United Therapeutics) has performed 1,100 EVLP procedures using other approved devices, with 600 lungs accepted for transplant. Lung Bioengineering expects to add LungFX to its available services in 2027.

Earlier this month, the company’s investigational external liver assist product miroliverELAP was granted Regenerative Medicine Advanced Therapy (RMAT) designation.

Comments from United Therapeutics, Lung Bioengineering, and clinicians

Martine Rothblatt, Ph.D., chairperson and CEO, United Therapeutics: “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. 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.”

Dr. Kenneth McCurry, MD, director of the Cleveland Clinic Enterprise Transplant Center and investigator in the LungFX pivotal trial: “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. 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 VP, Lung Bioengineering: “LungFX is the first EVLP device approved specifically for use in a fit-for-purpose centralized facility, expanding access for transplant programs without requiring them to build EVLP capabilities within their own hospitals. It also strengthens United Therapeutics’ platform for advancing new technologies designed to enhance donor lung function.”