Airiver Medical, a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions, announced on Wednesday that it has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its Airiver Pulmonary Drug Coated Balloon (DCB) to treat central airway stenosis.

The FDA Center for Devices and Radiological Health (CDRH) concluded that the product has a reasonable chance of providing more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions than the current standard of care.

Central airway stenosis, otherwise defined as airway narrowing, is often associated with prolonged intubation, tracheostomy, stenting, tuberculosis or lung transplant. Each year, approximately 100,000 tracheo-bronchial stenting and dilation procedures are performed in the United States.

Mitchell Erickson, Airiver Medical director of Research and Development, said: "Receiving this designation is extremely meaningful for us because with it, patients and health care 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."