Data shows in-office treatment of nasal valve collapse resulted in lasting improvement in symptoms and quality of life
SUNNYVALE, Calif. Aerin Medical today announced the publication of two-year results from a multi-center, prospective study that demonstrate significant, long-term relief for nasal obstruction sufferers who underwent treatment of nasal valve collapse with VivAer®. The results were published in the International Forum of Allergy and Rhinology.
The study found that 97.2% of patients had a significant and sustained reduction in their nasal obstruction symptoms through two years, without any significant device-related adverse events. The study assessed symptom burden using the gold-standard NOSE score before and after treatment for the 36 participants who remained for its duration. Initial three-month improvements were maintained at 12, 18 and 24 months.
“The study findings reinforce physician confidence in the long-lasting benefits of VivAer for the treatment of nasal airway obstruction caused by nasal valve collapse,” says Dr. Moshe Ephrat of ENT Allergy and Associates of Lake Success, New York and study lead investigator and co-author. “The long-term quality-of-life improvements, in-office convenience and non-invasive profile that minimizes patient downtime make VivAer a compelling option for the treatment of nasal obstruction.”
Nasal airway obstruction (NAO) is a common condition that impacts more than 20 million Americans1 and the condition 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.
The nasal valve is the narrowest part of the nasal airway, and even small changes in dimensions can create exponential reductions in airflow. Nasal valve collapse contributes to obstruction for 73% of highly symptomatic patients2 but is addressed much less frequently in NAO procedures. VivAer offers physicians a unique treatment modality by using temperature-controlled radiofrequency to remodel tissue in the nasal valve and increase its ability to resist collapse.
The published study showed that patients maintained a 67% improvement in symptoms over baseline two years after correction of nasal valve collapse with VivAer. Mean NOSE scores decreased from 80.8 at baseline (severe nasal obstruction) to 24.9 at 6 months, and 26.5 at 2 years post procedure (mild/moderate obstruction). Participants reported significant lasting improvement in quality of life—including significantly better sleep function, better concentration and productivity, and decreased feelings of frustration. Decreased use of oral medications, nasal sprays, and nasal breathing strips were also reported.
“Our mission is to offer the otolaryngology community innovative solutions to help the tens of millions of people who suffer from chronic nasal conditions,” says Matt Brokaw, CEO of Aerin Medical. “We are pleased with these study results and will continue to invest in building a robust body of clinical evidence to support the use of our products to treat these common conditions.”
VivAer® is a non-invasive in-office procedure for the treatment of nasal airway obstruction that uses patented temperature-controlled radiofrequency technology clinically demonstrated to provide long-term relief from nasal obstruction. VivAer features a thin, wand-like, temperature-controlled stylus that attaches to a console. The stylus is inserted via the nostril to gently remodel the nasal tissue and improve airflow. It is a single solution that can be used to treat all three anatomical contributors to NAO – lateral nasal wall, turbinates and septum. VivAer does not involve any cutting, freezing, or removal of nasal tissue or bone. Treatment with VivAer may be performed during a routine office visit with local anesthesia. Patients typically experience minimal discomfort with no downtime, often able to return to normal activities immediately following treatment.* The VivAer Stylus received CE Mark in 2016 and FDA 510(k) regulatory clearance in December 2017.
Aerin Medical is a privately held, venture-backed company with U.S. offices in Sunnyvale, California and Austin, Texas. Aerin’s mission is to provide ENT physicians with non-invasive procedures for the treatment of chronic nasal airway conditions. The company’s FDA-cleared 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 an in-office procedure performed with local anesthetic. More than 35,000 patients have been treated with Aerin Medical products to date. For more information, please visit www.aerinmedical.com.
*Individual results may vary
1Value calculated based on 2014 US population estimate from US Census and World Bank data in conjunction with incidence numbers cited in: Stewart M, Ferguson BJ, Fromer L. Epidemiology and burden of nasal congestion. Intl J Gen Med. 2010;3:37-45.
2Clark, David; Del Signore, Anthony; Raithatha, Roheen; Senior, Brent; 2018. Nasal airway obstruction: Prevalence and anatomic contributors; 2018 ENT Ear Nose & Throat Journal; 97(6)
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