The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. This FDA IDE – the company’s first — allows it to begin a pivotal clinical trial of the technology.

Central airway stenosis (airway narrowing) can lead to prolonged intubation, tracheostomy, stenting, tuberculosis or lung transplant. According to a news release, approximately 100,000 tracheo-bronchial stenting and dilation procedures take place annually in the U.S.

Airiver designed its DCB to combine standard balloon dilation with proprietary drug delivery. It aims to open the respiratory tract and deliver therapeutics designed to maintain symptom relief and prevent recurrence. The system’s proprietary coating enables very localized paclitaxel delivery to the stenosis while limiting levels in the surrounding healthy tissue.