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ProTractX3 is a drug-coated balloon (DCB) medical device developed by GIE Medical for the treatment of benign gastrointestinal strictures. It is a multi-stage, through-the-scope (TTS) balloon catheter coated with paclitaxel at a dose density of 3.5 μg/mm². The device provides mechanical dilation of strictures in the esophagus and bowel while simultaneously delivering paclitaxel to the local tissue. Paclitaxel acts as an anti-proliferative agent to inhibit fibrotic tissue growth and prevent restenosis (re-narrowing). It received FDA Breakthrough Device Designation in 2023 and is currently undergoing evaluation in the PATENT-E and PATENT-B clinical trials.
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