Airiver’s Drug-Coated Balloon Gains FDA Breakthrough Device Status

Airiver Medical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its pulmonary drug-coated balloon (DCB), designed to treat central airway stenosis. The designation, granted by the FDA’s Center for Devices and Radiological Health (CDRH), is intended to accelerate the development and review of technologies that may significantly improve treatment for serious or life-threatening conditions.

The device combines conventional balloon dilation to widen the airway with targeted drug delivery to enhance treatment outcomes.

The study, approved under an investigational device exemption, will enrol up to 200 patients across the US to assess the device’s safety and effectiveness.

Researchers believe the technology could address the lack of durable, minimally invasive therapies for recurrent airway stenosis. However, the Airiver DCB remains investigational and is not yet commercially available in the United States.

05-03-2026