Airiver Medical today announced the successful treatment of the first patient in a pivotal clinical trial of its drug-coated balloon (DCB). The first patient received treatment for chronic rhinosinusitis (CRS) in its RESTORE-2 U.S. pivotal clinical trial. It evaluates the Brooklyn Park, Minnesota-based company’s Airiver ESSpand sinus DCB. Dr. Andrew Gould treated the first patient […]
Airiver Medical
Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient
Airiver Medical announced today that it received FDA breakthrough device designation for its pulmonary drug-coated balloon (DCB). Additionally, Airiver announced the first treated patients in a clinical trial for the DCB. The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. Central airway stenosis (airway narrowing) can lead to prolonged intubation, tracheostomy, […]
Airiver Medical wins FDA IDE for pulmonary drug-coated balloon
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) […]
