New Trial Data Show VivAer Effectively Reduces Nasal Airway Obstruction Symptoms

Aerin Medical Inc. now has further clinical proof that its VivAer technology can effectively treat nasal airway obstruction (NAO).

Twelve-month data from the company’s VATRAC trial showed NAO symptoms caused by nasal valve collapse (NVC) improved after a single VivAer treatment. Previously published three-month study results demonstrated that VivAer treatment was safe and superior to a sham procedure.¹

“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.”
 
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%, 91%, and 89.8% at three, six, 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 three, six, 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.

“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.”
 
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, freezing, or removal of nasal tissue or bone. 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 immediately following treatment.* The VivAer Stylus received CE Mark in 2016 and U.S. Food and Drug Administration 510(k) clearance in December 2017. 

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, 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.
 
Aerin Medical is a privately held, venture-backed company, with U.S. offices in California and Texas. 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 in-office procedures performed with local anesthetic. More than 60,000 patients have been treated with Aerin Medical products to date. 
 
*Individual results may vary.

Reference
¹ Clark, David; Del Signore, Anthony; Raithatha, Roheen; Senior, Brent; 2018. Nasal airway obstruction: Prevalence and anatomic contributors; 2018 ENT Ear Nose & Throat Journal; 97(6).