United Therapeutics Corporation Announces FDA Approval of the LungFX™ Device for Centralized Ex Vivo Lung Perfusion
LungFX™ is the first device approved for centralized ex vivo lung perfusion for donor organs not otherwise used for transplant, an important step in advancing United Therapeutics’ platforms
United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of the LungFXTM device (LungFX) for use in centralized ex vivo lung perfusion (EVLP), a procedure that enables donor lungs to be assessed outside the body after procurement and before transplantation.
The PMA, submitted by United Therapeutics’ wholly owned subsidiary, Lung Bioengineering Inc., included comprehensive safety and effectiveness data supporting use of LungFX to perform EVLP in a centralized facility.
LungFX is indicated for centralized, ex vivo (outside the body) evaluation of deceased-donor lungs (single and double) that cannot be placed for transplantation by an organ procurement organization (OPO) with any of the matched candidates if using direct-to-recipient procurement and preservation procedures. LungFX provides normothermic perfusion and ventilation of procured donor lungs initially stored with cold static preservation solution.
