GIE Medical 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.
“The care of gastrointestinal strictures has been largely unchanged for decades,” said Nicholas J. Shaheen, MD, MPH, Bozymski-Heizer Distinguished Professor of Medicine and Chief, Division of Gastroenterology and Hepatology at the University of North Carolina School of Medicine. “This technology represents a promising way forward in treating those with difficult strictures and could result in less complicated, less costly and less invasive care for these patients.”
The FDA Center for Devices and Radiological Health (CDRH) granted GIE Medical the Breakthrough Device Designation to expedite development of its ProTractX3 TTS DCB for patient access because it has a reasonable chance of providing more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions than the current standard of care.
“We are honored to have our drug-coated balloon catheters selected for the FDA’s Breakthrough Device Program for esophageal strictures. This may provide U.S. patients faster access to our novel DCB technology, with the potential to provide safer and more effective treatment,” said Lixiao Wang, chairman and CEO of GIE Medical. “This designation will give U.S. gastrointestinal physicians exciting new tools to fight GI stenosis.”
GIE Medical’s ProTractX3 3-Stage TTS DCB is a balloon coated with the chemotherapeutic agent paclitaxel. It is an investigational device in the U.S.