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First of Its Kind Multi-Stage Drug-Coated Balloon Technology to Help Fight GI Stenosis

By HospiMedica International staff writers
Posted on 09 Jun 2023
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Image: ProTractX3 TTS DCB has been granted US FDA’s breakthrough device designation (Photo courtesy of GIE Medical)
Image: ProTractX3 TTS DCB has been granted US FDA’s breakthrough device designation (Photo courtesy of GIE Medical)

For decades, the approach to treating gastrointestinal (GI) strictures has remained largely unchanged. Now, an innovative technology offers a potential breakthrough in treating individuals with challenging GI strictures, leading to simpler, more cost-effective, and less invasive patient care.

GIE Medical (Brooklyn Park, MN, USA) has developed ProTractX3 TTS DCB for the dilation of recurring benign esophageal strictures in adult patients. These strictures, linked to the narrowing of the esophagus, cause obstructive symptoms in such patients. The ProTractX3 3-Stage TTS DCB is a balloon coated with the chemotherapeutic agent paclitaxel. This drug-coated balloon (DCB), deployable through the scope, presents a novel solution for GI stricture treatment, potentially ensuring long-term sustained patency and reducing the need for multiple treatments.

In December 2022, GIE Medical initiated two extensive, multicenter randomized controlled clinical trials in the United States. These trials are designed to examine the performance of the company's pioneering multi-stage DCB technology, ProTractX3 TTS DCB. The FDA Center for Devices and Radiological Health (CDRH) has awarded GIE Medical the Breakthrough Device Designation to speed up the development of its ProTractX3 TTS DCB. This designation is granted as the device shows significant potential to offer a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions compared to the existing 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."

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