PLYMOUTH, Minn., June 6, 2023 /PRNewswire/ — GIE Medical, a clinical stage company developing solutions for patients suffering from benign stricture(s) of the esophagus or bowel, was granted designation as a Breakthrough Device from the U.S. Food and Drug Administration (FDA) for its ProTractX3™ TTS DCB indicated for dilation of recurrent benign esophageal strictures in adults with obstructive symptoms associated with narrowing of the esophagus.
In December 2022, GIE Medical launched two large, multicenter randomized controlled clinical trials in the United States to investigate the company’s first of its kind multi-stage drug-coated balloon (DCB) technology, ProTractX3 TTS DCB.