Two-year results from a multi-center, prospective study demonstrate significant, long-term relief for people with nasal obstruction who underwent treatment of nasal valve collapse with Aerin Medical’s VivAer. The results were published in the International Forum of Allergy and Rhinology.
VivAer is an in-office procedure for the treatment of nasal airway obstruction that uses d temperature-controlled radiofrequency technology. It features a thin, wand-like, temperature-controlled stylus that attaches to a console. The stylus is inserted via the nostril to remodel the nasal tissue and improve airflow. The VivAer Stylus received CE Mark in 2016 and FDA 510(k) regulatory clearance in December 2017.
The newly published study found that 97.2% of patients had a significant and sustained reduction in their nasal obstruction symptoms through two years, without any significant device-related adverse events. The study assessed symptom burden using the NOSE score before and after treatment for the 36 participants who remained for its duration. Initial three-month improvements were maintained at 12, 18, and 24 months.
“The study findings reinforce physician confidence in the long-lasting benefits of VivAer for the treatment of nasal airway obstruction caused by nasal valve collapse,” says study lead investigator and coauthor Moshe Ephrat, MD, FACS, of ENT Allergy and Associates of Lake Success, NY, in a release. “The long-term quality-of-life improvements, in-office convenience, and noninvasive profile that minimizes patient downtime make VivAer a compelling option for the treatment of nasal obstruction.”
The nasal valve is the narrowest part of the nasal airway, and even small changes in dimensions can create exponential reductions in airflow.
The published study showed that patients maintained a 67% improvement in symptoms over baseline two years after correction of nasal valve collapse with VivAer. Mean NOSE scores decreased from 80.8 at baseline (severe nasal obstruction) to 24.9 at 6 months, and 26.5 at 2 years post procedure (mild/moderate obstruction). Participants reported significant lasting improvement in quality of life—including significantly better sleep function, better concentration and productivity, and decreased feelings of frustration. Decreased use of oral medications, nasal sprays, and nasal breathing strips were also reported.
“Our mission is to offer the otolaryngology community innovative solutions to help the tens of millions of people who suffer from chronic nasal conditions,” says Matt Brokaw, CEO of Aerin Medical, in a release. “We are pleased with these study results and will continue to invest in building a robust body of clinical evidence to support the use of our products to treat these common conditions.”