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Airiver Medical

Airiver treats first patient in drug-coated balloon study for chronic rhinosinusitis

June 11, 2026 By Sean Whooley

Airiver Medical Drug-Coated Balloon DCB (1) (1)

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. … [Read more...] about Airiver treats first patient in drug-coated balloon study for chronic rhinosinusitis

Filed Under: Balloons, Catheters, Coatings, Technologies & Devices Tagged With: Airiver Medical

Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient

March 4, 2026 By Sean Whooley

Airiver Medical Drug-Coated Balloon DCB (1) (1)

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 … [Read more...] about Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient

Filed Under: Balloons, Catheters, Coatings, FDA Breakthrough Designation, Regulatory, Technologies & Devices Tagged With: Airiver Medical, fda

Airiver Medical wins FDA IDE for pulmonary drug-coated balloon

August 27, 2025 By Sean Whooley

Airiver Medical Drug-Coated Balloon DCB (1) (1)

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 … [Read more...] about Airiver Medical wins FDA IDE for pulmonary drug-coated balloon

Filed Under: Balloons, Catheters, Coatings, Regulatory, Technologies & Devices Tagged With: Airiver Medical, fda

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