Airiver Medical, a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions, was granted designation as a Breakthrough Device from the FDA for its Airiver Pulmonary Drug Coated Balloon (DCB) to treat central airway stenosis.
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.
The first patient was enrolled and treated in Airiver Medical's pivotal clinical trial by Dr. Ashli O'Rourke, professor and director of laryngology at the Medical University of South Carolina. Airiver Medical received investigational device exemption (IDE) approval from the FDA to begin this U.S. pivotal clinical trial that will enroll up to 200 patients suffering from central airway stenosis to assess the safety and efficacy of the Airiver DCB. The technology 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 localized paclitaxel delivery to the stenosis, while limiting levels in the surrounding healthy tissue. The study is testing the Airiver DCB against standard of care bare balloon dilation. The study, if successful, will serve as the basis for Airiver Medical's regulatory submission to the FDA and eventual commercialization of the Airiver Pulmonary DCB in the U.S.
The Airiver DCB is an investigational device for treating benign central airway stenosis. The Airiver DCB has not received marketing authorization from the FDA and is not available for sale in the United States.
