Treatment with VivAer, a non-invasive, temperature-controlled radio frequency (RF) device, resulted in significant symptom relief that was superior to the sham control
Photo credit: (C) Aerin Medical, Inc.
Sunnyvale, Calif. – July 13, 2021 – Aerin Medical Inc., a company dedicated to providing non-invasive solutions to ear, nose and throat (ENT) doctors to treat chronic diseases of the nasal passages, announced today , that the International Forum for Allergy and Rhinology has published online three-month results of the VATRAC study confirming the safety and effectiveness of VivAer® in the treatment of nasal airway obstruction (NAO) due to nasal valve collapse (NVC). In the study, patients treated with VivAer showed a significant improvement in symptoms of nasal obstruction compared to the control group. This is the first randomized controlled trial of non-invasive radiofrequency treatment for NVC.
“The result of this study provides one of the highest clinical evidence for the use of VivAer in the treatment of nasal obstruction due to a collapsed nasal valve,” said Principal Investigator Joseph K. Han, MD, of the Department of Otorhinolaryngology – Head – and neck surgery at Eastern Virginia Medical School in Norfolk, Virginia and President of the American Rhinologic Society. “New, non-invasive treatment options that do not require incisions or incisions are remarkable for patients whose daily lives are hampered by the stress of a stuffy nose. This study builds on the growing evidence that VivAer is an attractive alternative to traditional surgical procedures for eligible patients. “
The VivAer Approach to the Treatment of Sinus Obstruction Study (VATRAC), a multicenter, prospective, single-blind, randomized, sham-controlled study that enrolled 117 patients with extreme or severe NAO based on the clinically validated Nasal Obstruction Symptom Rating Scale (NOSE ) with NVC as the primary or significant contributor to symptoms of nasal obstruction. Patients were randomized to undergo VivAer medical treatment (treatment group) or a sham medical procedure that replicated the treatment experience without releasing high-frequency therapeutic energy (control group).
The VATRAC study met its primary and secondary endpoints, with treated patients having a significantly better response rate (88.3% of patients in the treatment group had a NOSE score improvement of at least 20% versus 42.5% in the control group) and a Symptom reduction (55.1% showed% improvement in mean NOSE score in the treatment group compared to 21.3% improvement in the control group). Statistically significant improvements were seen in treated patients for nasal congestion, nasal congestion, improved breathing and sleep, and improved breathing with physical exertion or exertion. The authors found that patients treated with VivAer experienced similar relief from NAO symptoms as those who underwent more invasive surgical procedures. Subgroup analysis of the data also showed that VivAer was equally effective in treating patients with static and dynamic (occurring during inhalation) NVC. Treatment with VivAer was generally well tolerated and there were no serious procedural side effects.
NAO is a common condition affecting more than 20 million Americans1 and can be a heavy burden on daily life. The most common symptoms are nasal congestion or nasal congestion, difficulty breathing through the nose, difficulty sleeping, and difficulty breathing during exercise or exertion. NVC contributes to nasal congestion in 73% of severely symptomatic patients.2 but it is often underdiagnosed and left untreated. VivAer offers doctors a unique treatment method that gently remodels the tissue in the nasal valve and thus increases its resistance to collapse.
“We believe one reason NVC is often overlooked is the lack of non-invasive treatment options as an alternative to surgical repair,” said Scott Wolf, MD, founder and chief medical officer of Aerin Medical. “To date, more than 30,000 people have been treated with VivAer, and the compelling results from the VATRAC study reflect our commitment to building solid clinical evidence to support the safety and effectiveness of this non-invasive device.”
VivAer is a non-invasive technology that uses patented, temperature-controlled radio frequency energy that has been clinically proven to provide long-term relief from nasal obstruction. VivAer has a thin, wand-like stylus that attaches to a console. The pen is inserted through the nostril to gently reshape the nasal tissue and improve airflow. It is a single solution that can be used to address all three anatomical factors that contribute to NAO – the lateral nasal wall, turbinates, and the cavernous septum. VivAer does not involve cutting, freezing, or removing nasal tissue or bones. Treatment with VivAer can be carried out with local anesthesia during a routine doctor’s visit. Patients typically experience minimal discomfort with minimal to no downtime and can often return to normal activities immediately after treatment. * The VivAer stylus received CE mark in 2016 and FDA 510 (k) approval in December 2017.
About Aerin Medical
Aerin Medical is a privately held, venture backed company with US offices in Sunnyvale, California and Austin, Texas. Aerin’s mission is to provide ear, nose and throat (ENT) doctors with non-invasive solutions for the treatment of chronic diseases of the nasal passages. The company’s FDA-cleared products, VivAer® for nasal airway obstruction and RhinAer® for chronic rhinitis, use Aerin’s proprietary, temperature-controlled technology that enables ENT doctors to monitor symptoms in patients with an in-office procedure Reliably improve local anesthesia. To date, more than 35,000 patients have been treated with Aerin Medical products. Further information is available at http: // www.
* Individual results may differ.
1 Value calculated based on 2014 US population estimate from US Census and World Bank data in conjunction with incidence figures cited in: Stewart M, Ferguson BJ, Fromer L. Epidemiology and load of nasal congestion. Intl. J. Gen. Med . 2010; 3: 37-45.
2 Clark, David; Del Signore, Anthony; Raithatha, Roheen; Senior, Brent; 2018. Nasal airway obstruction: prevalence and anatomical factors; 2018 ENT Ear, nose and throat diary ; 97 (6)