FDA approves centralized EVLP device for donor lung assessment

On June 29, 2026, the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) to a centralized ex vivo lung perfusion (EVLP) device for assessment of deceased-donor lungs before lung transplantation. The device is designed to support the controlled evaluation of single or double deceased-donor lungs that cannot be placed by an organ procurement organization through standard direct-to-recipient procurement and preservation pathways, to inform their potential suitability for first-time transplantation in adults aged ≥18 years with end-stage lung disease. Donor lungs deemed suitable for transplantation after device assessment require a second period of cold static preservation, with the cumulative preservation time not intended to exceed 20 hours. The device maintains procured donor lungs under normothermic perfusion and ventilation following initial cold static preservation. 

Safety and effectiveness data of the EVLP device are derived principally from the CLES Pivotal Study (NCT03641677), which prospectively evaluated outcomes with centralized EVLP within 1 year of organ preservation and transplantation, with additional observational survival follow-up at 2 years. The observed 12-month survival rate among recipients of EVLP-assessed lungs did not meet the prespecified performance goal (>95% posterior probability of 1-year survival >81.2%). Rates of 12-month overall mortality and Clinical Events Committee-adjudicated lung graft-related mortality were higher in EVLP recipients vs non-EVLP contemporaneous controls. Two-year survival was also less favorable among EVLP recipients across several prespecified subgroups. Reported adverse events included death, primary graft dysfunction (PGD), chronic lung allograft dysfunction (CLAD), respiratory failure, and allograft rejection. Physicians are advised to consider the risks and benefits of the device and other organ preservation modalities and to review the available clinical data in the device labeling before use.