Results from the AERWAY study were recently published and show the safety and efficacy of Aerin Medical Inc’s VivAer for treating patients with nasal airway obstruction due to nasal valve collapse. In the study, published in the Journal of Otolaryngology and Rhinology, patients experienced significant nasal obstruction symptom improvements at three months following treatment.

“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,” says William Yao, MD, the study’s principal investigator from the Department of Otorhinolaryngology – Head and Neck Surgery at McGovern Medical School at The University of Texas Health Science Center at Houston, in a release. “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.”

The AERWAY study, a prospective, multi-center single-arm trial, enrolled 122 adult patients with severe or extreme Nasal Obstruction Symptom Evaluation (NOSE) scores, for whom nasal valve collapse was a primary or significant contributor. Data from the AERWAY study show that patients treated with VivAer experienced significant symptom improvements as well as high rates of satisfaction three months following treatment. Among the study population:

  • A significant improvement of 59% was observed in mean total NOSE scores from baseline to 3 months (a decrease from 80.3 to 32.9, respectively; p<0.001).
  • 91.6% of patients responded to treatment, demonstrating either a 20% improvement in total NOSE score relative to baseline or at least one severity category improvement in their NOSE score.
  • 87.3% of patients treated indicated they would recommend VivAer to a friend.

This study will continue to follow up with the patients through two years to evaluate the durability of the procedure’s effects, but the authors noted that three-month results have been shown to be predictive of long-term outcomes in other studies.

“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,” says Matt Brokaw, CEO of Aerin Medical, in a release. “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.”

Nasal airway obstruction can take a heavy toll on daily life. The most common symptoms include nasal congestion or stuffiness, trouble breathing through the nose, trouble sleeping, and difficulty breathing well during exercise or exertion. Nasal valve collapse contributes to nasal obstruction for 73% of highly symptomatic patients, but is often under-diagnosed and left untreated.

VivAer offers ENT physicians a treatment modality that remodels tissue in the nasal valve.