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

Shots:

• Airiver Medical has received the US FDA’s IDE approval to initiate trial for Airiver Pulmonary Drug Coated Balloon (DCB) for the treatment of central airway stenosis
• The study will assess safety & efficacy of Airiver Pulmonary DCB against SoC bare balloon dilation in ~200 pts with central airway stenosis & support the US FDA submission & commercialization
• Airiver DCB combines balloon dilation to open the airway with a proprietary paclitaxel coating for localized drug delivery for maintaining symptom relief, preventing restenosis, & minimizing drug exposure to surrounding healthy tissue

Ref: PR Newswire | Image: Airiver Medical | Press Release

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