Airiver Medical, a clinical stage company developing technologies to help patients with certain respiratory tract conditions, said on Wednesday that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA), enabling the company to begin a pivotal clinical trial of the Airiver Pulmonary Drug Coated Balloon (DCB) to treat central airway stenosis.

This is Airiver's first IDE study submission and approval.

Planned to enrol up to 200 patients with central airway stenosis, the study aims to assess the safety and efficacy of the Airiver DCB, which combines standard balloon dilation to open the respiratory tract with proprietary drug delivery designed to maintain symptom relief and prevent recurrence.

The proprietary coating allows for very localised paclitaxel delivery to the stenosis, while limiting levels in the surrounding healthy tissue.