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The Airiver Paclitaxel-Coated Pulmonary Balloon is an investigational drug-device combination developed by Airiver Medical for the treatment of benign central airway stenosis (BCAS). The device consists of a pulmonary balloon catheter coated with paclitaxel, a microtubule-stabilizing agent that functions as an antiproliferative drug. During bronchoscopic intervention, the balloon is inflated to mechanically dilate the stenotic airway, while the proprietary coating facilitates the localized delivery of paclitaxel to the airway wall. This targeted delivery is designed to inhibit the inflammatory and fibroproliferative processes that lead to tissue regrowth and restenosis, thereby maintaining airway patency longer than standard balloon dilation. The device has been evaluated in the OXYGEN-1 first-in-human trial and is progressing into a pivotal clinical trial under an FDA Investigational Device Exemption (IDE).
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