Airiver Medical Receives FDA Breakthrough Device Designation for Airiver DCB and Treats First Patient with Central Airway Stenosis

Shots:

• The US FDA has granted BDD to Airiver Pulmonary Drug Coated Balloon (DCB) to treat central airway stenosis
• Additionally, the first patient has been enrolled & treated in a trial evaluating the Airiver DCB vs SoC bare balloon dilation in ~200 pts with central airway stenosis; positive results could support a future FDA regulatory submission
• Airiver DCB combines balloon dilation to reopen the airway with localized paclitaxel delivery via a proprietary coating designed to prolong symptom relief & reduce stenosis, while minimizing drug exposure to surrounding healthy tissue

Ref: PRnewswire   |   Image: Airiver Medical   |   Press Release

Related News: Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis

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