Aerin Medical has reported positive four-year results from a clinical trial of VivAer, its non-invasive technology for nasal airway obstruction (NAO).
VivAer uses temperature-controlled radiofrequency energy to provide long-term relief from nasal obstruction symptoms.
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It comprises a thin, wand-like stylus attached to a console. This stylus is inserted through the nostril to gently remodel the nasal tissue and improve airflow.
In December 2017, VivAer Stylus received FDA 510(k) clearance. The technology had previously received CE Mark in 2016.
Published in the International Forum of Allergy & Rhinology, the findings demonstrated VivAer treatment’s long-term durability in patients with NAO that is caused due to nasal valve collapse (NVC).
The study involved 29 patients with chronic severe or extreme NAO with NVC that had previously participated in a prospective multicentre study with follow-ups at six, 12, 18 and 24 months.
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By GlobalDataThe study was extended to further follow the cohort out to 48 months.
The follow-up study showed that the patients experienced significant and sustained improvement in NAO symptoms through four years after receiving treatment with VivAer for NVC.
The company stated that the average baseline (pre-procedure) Nasal Obstruction Symptom Evaluation (NOSE score) of the trial participants was 81.
After 48 months, NOSE scores decreased to 25.7 in the follow-up study.
Aerin Medical CEO Matt Brokaw said: “These study results represent the longest-term published outcomes for treatment with VivAer.
“We appreciate the efforts of the physician investigators and trial patients who have contributed over the past four years to demonstrate the significant, long-term benefits of temperature-controlled radiofrequency for chronic nasal obstruction caused by NVC.”
