SUNNYVALE, Calif.– Aerin Medical Inc., a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, today announced that JAMA Otolaryngology – Head & Neck Surgery published positive 12-month active treatment group outcomes from the VATRAC trial. Participants in the index active and crossover active treatment arms of the study showed durable improvement in symptoms of nasal airway obstruction (NAO) caused by nasal valve collapse (NVC) over baseline at 12 months following a single treatment with VivAer®. Previously published three-month results of the randomized controlled portion of the trial demonstrated that treatment with VivAer was safe and superior to a sham procedure.1
“Nasal valve collapse is a primary contributor to nasal airway obstruction, which often lowers quality of life due to symptoms including nasal congestion, headache, sleep disturbance, daytime sleepiness and snoring,” said Joseph K. Han, M.D., professor, chief of the Division of Rhinology & Endoscopic Sinus and Skull Base Surgery, and chief for the Division of Allergy at Eastern Virginia Medical School, who served as the co-principal investigator of the VATRAC clinical trial. “This study demonstrates that treatment with VivAer is a compelling non-invasive alternative for NAO patients and reinforces physician confidence in the consistent and lasting results of this treatment.”
VATRAC, a prospective, multi-center randomized control trial, enrolled 119 patients who had extreme or severe NAO, based on Nasal Obstruction Symptom Evaluation (NOSE) Scale score, with NVC as a primary or significant contributor to symptoms. Patients were randomized to undergo in-office treatment with VivAer or an in-office sham procedure. After primary endpoint analysis and unblinding, 31 patients were eligible for crossover, and all elected to undergo active VivAer treatment. The data included in this publication were collected from 108 patients, including crossovers from the control arm.
