Aerin Medical announced positive two-year outcomes from the VATRAC trial, which showed a single in-office treatment with VivAer resulted in sustained improvement in symptoms of nasal airway obstruction caused by nasal valve collapse, and reduced both daytime sleepiness and the use of medications and mechanical aids.
The study is published in Rhinology Journal. Previously published three-month results of the randomized controlled trial demonstrated that treatment with VivAer was safe and superior to a sham procedure.
“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,” says Joseph K. Han, MD, 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, in a release. “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 nasal airway obstruction based on the validated Nasal Obstruction Symptom Evaluation scale score, with nasal valve collapse as a primary or significant contributor to nasal airway obstruction symptoms. The most common symptoms of nasal airway obstruction 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 nasal airway obstruction symptoms significantly improved over baseline at all follow-up time points; 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,” says Matt Brokaw, CEO of Aerin Medical, in a release. “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.”
Nasal valve collapse contributes to nasal obstruction for 73% of highly symptomatic individuals but is often underdiagnosed 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.
Photo caption: VivAer
Photo credit: Aerin Medical