GIE Medical Granted FDA's Breakthrough Device Designation for Multi-Stage Drug Coated Balloon to Treat Esophageal Strictures
Designation may provide
In
"The care of gastrointestinal strictures has been largely unchanged for decades," said
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
GIE Medical's ProTractX3 3-Stage TTS DCB is a balloon coated with the chemotherapeutic agent paclitaxel. It is an investigational device in the
ABOUT GIE MEDICAL
GIE Medical is a clinical stage company conducting trials in the
The ProTractX3™ Through the Scope Drug Coated Balloon could offer a new solution for treating GI strictures, potentially creating sustained long-term patency and reducing the number of treatments. For more information, visit www.GIEMedical.com.
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SOURCE GIE Medical
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