Airiver Medical has secured the US Food and Drug Administration (FDA) breakthrough device designation for its pulmonary drug-coated balloon (DCB) intended for the treatment of central airway stenosis.
The designation aims to expedite development and patient access for devices with the potential to provide effective diagnosis or treatment of life-threatening conditions, compared to existing standards of care.
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The FDA’s Center for Devices and Radiological Health (CDRH) granted the status.
Airiver Medical said that the first patient was treated with the DCB by Medical University of South Carolina professor and director of laryngology Dr Ashli O’Rourke in a pivotal clinical trial.
The company secured investigational device exemption (IDE) approval from the FDA to initiate this US-based study, which will include up to 200 participants with central airway stenosis. The trial aims to evaluate both efficacy and safety of the Airiver DCB.
The device uses standard balloon dilation for opening the respiratory tract with drug delivery. The trial results will support a future regulatory submission for marketing authorisation in the US.
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By GlobalDataDr O’Rourke said: “Central airway stenosis is a debilitating condition with no minimally invasive, long-lasting treatment. This technology has the potential to provide a life-changing treatment option. That’s why I’m thrilled to treat the first patient in this potentially groundbreaking clinical trial.”
Airiver Medical’s research and development director Mitchell Erickson said: “Receiving this designation is extremely meaningful for us because with it, patients and healthcare providers may gain more timely access to our novel DCB technology, with the potential to provide safer and more effective treatment.
“The Airiver DCB has the potential to fill a gap that currently exists, as there is no optimal treatment of recurrent airway stenosis available as part of today’s treatment paradigm.”
The DCB currently remains an investigational device and is not available for sale in the US.
