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United Therapeutics (UTHR), in Collaboration with XVIVO Perfusion, Inc., Reports FDA Approval Of XPS and Steen Solution

April 29, 2019 6:10 AM EDT

United Therapeutics Corporation (NASDAQ: UTHR) today announced that its collaborator, XVIVO Perfusion, Inc., a subsidiary of XVIVO Perfusion AB (XVIVO), has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the products XPS and STEEN Solution. This approval means that STEEN Solution, XPS and the accompanying single-use articles are the only medical device products that are approved in the United States for ex-vivo lung perfusion (EVLP) of initially unacceptable donated lungs at body temperature.

In June 2018, United... More