Aerin Medical has announced positive safety and efficacy results from AERWAY study of VivAer device in treating nasal airway obstruction (NAO) due to nasal valve collapse (NVC).
VivAer is a non-invasive technology that leverages patented, temperature-controlled radiofrequency energy to provide long-term relief from nasal obstruction.
Featuring a thin, wand-like stylus that attaches to a console, the device is inserted through the nostril to gently remodel the nasal tissue and improve airflow.
VivAer is said to treat the lateral nasal wall, along with turbinates and septal swell bodies that cause NAO, without involving any cutting, freezing, or removal of nasal tissue or bone.
The company has received the CE Mark approval for VivAer Stylus in 2016 and the US Food and Drug Administration 510(k) approval in December 2017.
Aerin Medical CEO Matt Brokaw said: “Aerin Medical is committed to working closely with the otolaryngology community and societies to build strong clinical evidence around the use of non-invasive solutions for chronic nasal airway conditions.
“We appreciate the efforts of dozens of physician investigators involved in clinical trials demonstrating the significant benefits of our products and addressing the growing interest in treating the lateral nasal wall in appropriate patients.”
AERWAY trial enrolled 122 adult patients with severe or extreme Nasal Obstruction Symptom Evaluation (NOSE) scores, for whom NVC was a primary or significant contributor.
In the study, the treatment using VivAer showed significant relief in nasal obstruction symptoms, with a 59% improvement in mean total NOSE scores, after three months.
The device achieved 91.6% patient response, with either 20% improvement in total NOSE score or at least one severity category improvement in their NOSE score.
Aerin said that its AERWAY study will continue to follow-up through two years and will add value to increasing evidence supporting the safety and efficacy of VivAer.
AERWAY study principal investigator William Yao said: “Nasal valve collapse is a common problem for the 20 million Americans suffering from nasal airway obstruction, but treatment options have historically been limited for otolaryngologists.
“For patients who don’t respond to medications, temporary aids like breathing strips may not be practical, and traditional surgical procedures in the operating room have had a limited role.
“The results of this study showed that temperature-controlled radiofrequency energy could be a reliable and effective treatment.”
