Airiver Medical wins FDA IDE for pulmonary drug-coated balloon

Airiver Medical Receives IDE Approval from the FDA for Pivotal Clinical Study of the Airiver Pulmonary Drug Coated Balloon to Treat Benign Central Airway Stenosis

The nationwide study will assess the safety and efficacy of the technology that combines standard balloon dilation to open the respiratory tract with drug delivery designed to maintain symptom relief

Airiver Medical wins FDA IDE for pulmonary drug-coated balloon

The Airiver Medical drug-coated balloon. [Image from the company website] Airiver Medical announced today that it received FDA investigational device exemption (IDE) for its pulmonary drug-coated balloon (DCB). 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) c…