The FDA Center for Devices and Radiological Health (CDRH) granted Airiver Medical the Breakthrough Device Designation to expedite development of its Pulmonary Drug Coated Balloon (DCB) for patient access because it 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.

“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,” said Mitchell Erickson, Director of Research and Development for Airiver Medical. “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.”