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 U.S. 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) 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.”
First Patient Treated in Clinical Trial
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.
“Central airway stenosis is a debilitating condition with no minimally invasive, long-lasting treatment,” said Dr. O’Rourke. “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.”
Central airway stenosis, otherwise defined as airway narrowing, is often associated with prolonged intubation, tracheostomy, stenting, tuberculosis or lung transplant. There are approximately 100,000 tracheo-bronchial stenting and dilation procedures performed annually in the United States.
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.