United Therapeutics Corporation (NASDAQ:UTHR) said Monday that the U.S.
Food and Drug Administration (FDA) has granted premarket approval for its LungFX device, marking a significant step in the company's efforts to increase the number of donor lungs available for transplantation.
The approval covers the use of LungFX in centralized ex vivo lung perfusion (EVLP), a process that allows donor lungs to be evaluated outside the body after they are procured and before transplantation.
Read Also: United Therapeutics' Trial Shows 55% Drop in Lung Disease Worsening FDA Clears Device For Centralized EVLP Procedures The premarket approval application was submitted by United Therapeutics' wholly owned subsidiary, Lung Bioengineering, and included safety and efficacy data supporting the use of LungFX in centralized EVLP facilities.
LungFX is designed to assess deceased-donor lungs that cannot initially be matched to recipients through traditional direct-to-recipient procurement and preservation methods.
