New 12-month Results from the VATRAC Trial Confirm Durable Efficacy of Aerin Medical’s VivAer® in Patients with Nasal Valve Collapse

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Summation

  • 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.
  • 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®.
  • “The growing clinical body of evidence supporting the efficacy of VivAer has also contributed to the increased momentum in adoption from the ENT community, and now more than 50,000 patients have been treated with VivAer since it was first introduced in 2018.

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.

The VATRAC study outcomes demonstrate ongoing effectiveness and safety of VivAer, with treated patients reporting durable improvement from baseline at 12 months post-procedure. Specific results included:

  • Consistent high responder rates through the first year (86.0%, 91.0% and 89.8% at 3, 6, and 12 months, respectively). Responders are defined as patients with a ≥20% decrease in NOSE-scale score or ≥1 NOSE-scale severity category improvement from baseline.
  • Improvements in symptoms of NAO (53.6%, 56.6% and 58.8% at 3, 6, and 12 months, respectively, over baseline in the average NOSE-scale score).
  • VivAer was effective in reducing symptoms of NAO regardless of the mechanism of NVC (static and dynamic).
  • Decreased medication and mechanical nasal aid usage at 12 months compared to baseline.
  • Less fatigue during the day, with less daytime sleepiness at 12 months as measured by the Epworth Sleepiness Scale.
  • Treatment with VivAer was well-tolerated, with no serious adverse events related to the procedure or device.

“Study after study, physician investigators have demonstrated that treatment with VivAer results in significant, sustained improvements in nasal airway obstruction symptoms,” said Matt Brokaw, CEO of Aerin Medical. “The growing clinical body of evidence supporting the efficacy of VivAer has also contributed to the increased momentum in adoption from the ENT community, and now more than 50,000 patients have been treated with VivAer since it was first introduced in 2018.”

NAO can take a heavy toll on daily life. The most common symptoms include nasal congestion or stuffiness, trouble breathing through the nose, trouble sleeping, and difficulty breathing well during exercise or exertion. NVC 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.

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