Aerin Medical Inc., a company dedicated to providing Ear, Nose and Throat (ENT) physicians with non-invasive solutions for the treatment of chronic nasal conditions, announced that Rhinology Journal has published positive two-year outcomes from the VATRAC trial.
The study showed a single in-office treatment with VivAer® resulted in sustained improvement in symptoms of nasal airway obstruction (NAO) caused by nasal valve collapse, and reduced both daytime sleepiness and the use of medications and mechanical aids. Previously published three-month results of the randomized controlled trial demonstrated that treatment with VivAer was safe and superior to a sham procedure.1
“These data demonstrating the significant and lasting improvements in nasal airway obstruction symptoms mark a breakthrough in addressing a common and often-challenging cause of the condition,” said Joseph K. Han, M.D., professor, chief of the division of rhinology and 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. “VivAer offers lasting relief to patients with nasal airway obstruction symptoms and creates new options for complete treatment of the nasal valve.”
VATRAC, a prospective, multi-center randomized control trial, enrolled 119 patients who had extreme or severe NAO based on the validated Nasal Obstruction Symptom Evaluation (NOSE) Scale score, with nasal valve collapse as a primary or significant contributor to NAO symptoms. The most common symptoms of NAO include nasal congestion or stuffiness, trouble breathing through the nose, trouble sleeping and difficulty breathing well during exercise or exertion. After primary endpoint analysis, 31 control patients were eligible for crossover and elected to undergo active VivAer treatment. The data in this two-year post-procedure publication includes 73 patients receiving VivAer treatment, including these crossovers.
The long-term follow up from VATRAC confirmed the sustained effectiveness of VivAer, with treated patients reporting durable improvements from baseline through 24 months post-procedure, including in those with documented septal deviation. Key findings included:
The responder rate at two years was 90.4%, sustained across all time periods.
Patient NAO symptoms significantly improved over baseline at all follow-up timepoints; at two years post-treatment, patients maintained a 54.7% improvement in NOSE scores compared to baseline.
The presence of septal deviation did not significantly affect treatment outcomes.
Treatment with VivAer was well-tolerated, and there were no serious adverse events related to the procedure or device.
“This publication adds to the deep dossier of clinical evidence for VivAer, with three separate studies now confirming multi-year benefit and with comparable responder rates,” said Matt Brokaw, CEO of Aerin Medical. “We extend our gratitude to the clinical investigators whose dedication has been instrumental in demonstrating that VivAer is a practical and effective innovation changing how and where nasal airway obstruction patients are treated.”
NAO takes a heavy toll on daily life. Nasal valve collapse contributes to nasal obstruction for 73% of highly symptomatic individuals,2 but is often under-diagnosed and left untreated. This can have a significant impact on a person’s quality of life, as the nasal valve is the narrowest part of the nasal airway and even small obstructions can create an exponential reduction in airflow. VivAer offers ENT physicians a unique, non-invasive and office-friendly option that durably remodels tissue in the nasal valve to address NAO in appropriate patients.
VivAer is a non-invasive technology that uses patented, temperature-controlled radiofrequency energy and is clinically demonstrated to provide long-term relief from nasal obstruction. VivAer features a thin, wand-like stylus that attaches to a console. The stylus is inserted via the nostril to gently remodel the nasal tissue and improve airflow. VivAer does not involve any cutting, removal of nasal tissue or bone, or the use of an implant. Treatment with VivAer may be performed during an office visit with local anesthesia. Patients typically experience little discomfort with minimal to no downtime and are often able to return to normal activities following treatment. The VivAer Stylus received CE Mark in 2016 and FDA 510(k) clearance in December 2017.
For more information, visit www.VivAer.com.