GIE Medical, a clinical-stage company focusing on solutions for patients with benign strictures of the esophagus or bowel, has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for their ProTractX3™ TTS DCB. This designation is granted to medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions.
In December 2022, GIE Medical initiated two large, multicenter randomized controlled clinical trials in the United States to investigate their innovative multi-stage drug-coated balloon (DCB) technology, ProTractX3 TTS DCB. The goal is to offer a less complicated, cost-effective, and minimally invasive care option for patients with challenging strictures. The Breakthrough Device designation from the FDA's Center for Devices and Radiological Health (CDRH) aims to expedite the development and availability of such devices that have the potential to significantly improve patient outcomes.
GIE Medical's ProTractX3 3-Stage TTS DCB is a balloon coated with paclitaxel, a chemotherapeutic agent. It is intended for dilation of recurrent benign esophageal strictures in adults with obstructive symptoms associated with esophageal narrowing. This device is currently undergoing investigation in the United States.