Study Confirms Long-Term Efficacy of Aerin Medical’s VivAer Treatment

Aerin Medical Inc. is sharing positive three-year results from VATRAC, a randomized controlled trial validating the safety, efficacy, and durability of VivAer temperature-controlled radiofrequency (TCRF) therapy for nasal obstruction due to nasal valve collapse. At the three-year mark, 87% of enrolled patients were considered treatment responders, with a mean Nasal Obstruction Symptom Evaluation (NOSE) score improvement of 64.6% from baseline.

No serious procedure or device-related adverse events were reported throughout the study, confirming the procedure’s strong safety profile. Published in the White Journal, the study highlights significant and sustained improvements in nasal airflow, sleep quality, and quality of life.

The prospective multicenter study evaluated 108 patients with severe or extreme nasal airway obstruction (NAO). Patients treated with VivAer experienced significant improvements in NAO symptoms as measured by the validated NOSE score scale and daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS).

“The study results demonstrate that TCRF treatment with Aerin’s VivAer device provides patients with not only long-term relief from nasal airway obstruction symptoms but also meaningful improvements in sleep quality and reduced dependence on medications,” stated Joseph K. Han, M.D., professor, vice chair of Clinical Affairs and chief for the division of allergy at Old Dominion University, who served as the study’s co-principal investigator. “For ENTs and their patients, this offers a safe and minimally invasive alternative to surgical interventions with sustained outcomes.”

Key Study Findings

• Durable Symptom Relief: Patients reported a 64.6% improvement in NOSE scores, with significant reductions in nasal congestion, nasal blockage, and difficulty breathing.
• Reduced Daytime Sleepiness: Daytime sleepiness scores improved significantly at three years, with ESS score mean change of -4.85 compared to baseline for the overall group. Among patients with baseline ESS scores of ≥11 (mild-to-severe excessive daytime sleepiness), improvements were even more pronounced, with an adjusted mean change of -8.8.
• Decrease in Medication Burden: Many patients reduced or discontinued their NAO medication usage at year three post procedure:
  • 69.2% decreased or stopped decongestants
  • 66.7% decreased or stopped intranasal steroid sprays
  • 53.6% of patients decreased or stopped oral antihistamines
  • 42.9% decreased or stopped leukotriene inhibitors

“This long-term study underscores the durability and effectiveness of VivAer as a minimally invasive solution for treating NAO caused by nasal valve collapse,” Aerin Medical CEO Matt Brokaw stated. “We are proud of our partnership with ENT physicians, who have used our VivAer system to help over 100,000 patients improve their quality of life.”

The nasal valve is the narrowest part of the nasal airway and even minor obstructions in the nasal valve can drastically reduce airflow and profoundly affect quality of life. VivAer provides ENT physicians with a non-invasive solution designed to durably remodel nasal valve tissue and effectively address NAO in suitable 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. It 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, nasal tissue or bone removal, or use an implant. VivAer treatment may be performed during an office visit with local anesthesia. Patients typically experience little discomfort with minimal downtime and are often able to return to normal activities following treatment. The VivAer Stylus received CE Mark in 2016 and U.S. Food and Drug Administration 510(k) clearance in December 2017.

Aerin Medical is a privately held, venture-backed company, headquartered in Mountain View, Calif. Aerin’s mission is to expand access to meaningful relief for millions of patients suffering from chronic ENT conditions. The company’s products—VivAer for nasal airway obstruction and RhinAer for chronic rhinitis—leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with technologies that are alternatives to invasive surgery. More than 150,000 patients have been treated with Aerin Medical products to date.