The health technology company published the positive two-year follow-up data from the AERWAY trial that evaluated patients with severe or extreme NAO due to nasal valve collapse (NVC)
Aerin’s VivAer improves NAO symptoms in study. (Credit: Business Wire)
US-based Aerin Medical announced that its VivAer technology has shown a significant and long-term improvement in nasal airway obstruction (NAO) symptom burden in the AERWAY trial.
VivAer is said to be a non-invasive technology that employs patented, temperature-controlled radiofrequency energy to offer long-term relief from nasal obstruction.
The health technology company published the positive two-year follow-up data from the AERWAY trial that evaluated patients with severe or extreme NAO due to nasal valve collapse (NVC).
The results were published online in Laryngoscope Investigative Otolaryngology.
According to Aerin, the AERWAY outcomes indicated the ongoing efficacy and safety of VivAer. The treated patients showed sustained two-year symptom improvement that was consistent with three-month, six-month, and one-year results.
In the trial, the symptom burden’s improvement was statistically significant and sustained. It was achieved in all subpopulations including NVC patients with untreated septal deviations and either static or dynamic NVC.
Additionally, improvements in the total Nasal Obstruction Symptom Evaluation (NOSE) Scale scores were sustained from the start of treatment for two years in 90.1% of the patients who responded.
Furthermore, the use of oral medications, nasal sprays and breathing strips lowered at two years against the baseline. VivAer treatment was also well-tolerated, with no serious adverse events.
Aerin Medical CEO Matt Brokaw said: “The positive two-year outcomes from the AERWAY trial build upon published VivAer clinical results, including superior symptom improvements in a randomized controlled trial and a four-year study showing long-term durability of a single VivAer treatment.
“We are proud to see the growing body of evidence that demonstrates the safety, effectiveness and predictability of VivAer for patients suffering from NAO due to NVC, and we thank the numerous physician investigators who have confirmed benefits for their patients.”
The AERWAY study is a prospective, multi-centre trial. It followed patients after a single therapy session with VivAer and gathered two-year data from 91 patients.
Aerin’s technology has a thin, wand-like stylus that attaches to a console. It is inserted via the nostril to gently remodel the nasal tissue and improve airflow.