FDA Awards Breakthrough Device Designation to Airway Medical’s Pulmonary Drug Coated Balloon

Airiver Medical has earned Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Airiver Pulmonary Drug Coated Balloon (DCB) central airway stenosis treatment. 

The FDA’s 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 care standard.

“Receiving this designation is extremely meaningful for us because with it, patients and healthcare providers may gain more timely access to our 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.”

Clinical Trial Begins

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 FDA investigational device exemption (IDE) approval to begin this U.S. trial that will enroll up to 200 patients suffering from central airway stenosis and will 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 the standard of care bare balloon dilation. If successful, the study will serve as the basis for Airiver Medical’s FDA submission and eventual U.S commercialization of the Airiver Pulmonary DCB.

“Central airway stenosis is a debilitating condition with no minimally invasive, long-lasting treatment,” Dr. O’Rourke stated. “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 U.S. sale.

Airiver Medical is a clinical stage company developing technologies to help patients suffering from certain respiratory tract conditions. The company aims to improve the current care standard for central airway stenosis and chronic rhinosinusitis. Airiver Medical’s Drug Coated Balloon could offer a new solution for these conditions, potentially creating sustained patency, better outcomes, and fewer treatments.