Airiver Medical Secures FDA Breakthrough Device Status for Novel Pulmonary Balloon
Airiver Medical has announced that its Pulmonary Drug-Coated Balloon (DCB) has received Breakthrough Device designation from the U.S. Food and Drug Administration.
The device is being developed to treat central airway stenosis, a condition where the main airways become constricted, causing breathing difficulties.
The FDA’s Breakthrough Device program is designed to accelerate the development and review of technologies that could offer substantial improvements over existing treatments for serious health conditions.
The Airiver Pulmonary DCB works by physically widening narrowed airways using balloon dilation while simultaneously delivering a drug coating to the targeted area.
The paclitaxel coating is intended to maintain the airway opening and reduce the risk of re-narrowing, while limiting exposure to healthy tissue.
With FDA clearance for an Investigational Device Exemption, Airiver Medical has begun a key U.S. clinical trial.
The study aims to enroll up to 200 participants to assess how the drug-coated balloon performs compared with conventional, uncoated balloon dilation.
The trial’s first patient was treated by Ashli O’Rourke at the Medical University of South Carolina.
The Airiver Pulmonary DCB is still investigational and has not yet been approved for general use in the United States.
