July 13, 2021 - Aerin Medical Inc., a company dedicated to providing Ear Nose and Throat (ENT) physicians non-invasive solutions for the treatment of chronic nasal airway conditions, today announced that the International Forum of Allergy and Rhinology has published three-month results online from the VATRAC trial, confirming the safety and efficacy of VivAer® for the treatment of nasal airway obstruction (NAO) caused by nasal valve collapse (NVC). In the study, those treated with VivAer showed significant improvement in nasal obstruction symptoms compared to the control group. This is the first randomized controlled trial of a non-invasive, radiofrequency treatment of NVC.
"The outcome of this study provides one of the highest levels of clinical evidence to support the use of VivAer in treating nasal airway obstruction due to nasal valve collapse," said co-principal investigator Joseph K. Han, M.D., of the Department of Otolaryngology - Head and Neck Surgery at the Eastern Virginia Medical School, in Norfolk, Virginia, and president of the American Rhinologic Society. "New, non-invasive treatment options that don't require cuts or incisions are remarkable for patients whose daily lives are impacted by the burden of nasal congestion. This study builds on the growing body of evidence that VivAer provides an attractive alternative to traditional surgical procedures for appropriate patients."
The VivAer procedure for Treatment of Nasal Airway Obstruction Study (VATRAC), a multi-center, prospective, single-blinded, randomized, sham-controlled trial, enrolled 117 patients who had extreme or severe NAO, based on the clinically validated Nasal Obstruction Symptom Evaluation (NOSE) Scale score, with NVC as a primary or significant contributor to their nasal obstruction symptoms. Patients were randomized to undergo in-office treatment with VivAer (treatment group) or an in-office sham procedure that replicated the treatment experience without delivering therapeutic radiofrequency energy (control group).
The VATRAC study met its primary and secondary endpoints, with treated patients demonstrating a significantly superior responder rate (88.3% of the treatment group patients had at least a 20% improvement in NOSE score versus 42.5% in the control group) and symptom reduction (55.1% improvement in mean NOSE score in the treatment group compared to 21.3% improvement in the control group). Statistically significant improvements were observed for treated patients in nasal congestion, nasal blockage, improved breathing and sleeping, and improved breathing during exercise or exertion. The authors noted that patients treated with VivAer experienced NAO symptom relief similar to 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, with no serious adverse events related to the procedure.
NAO is a common condition that impacts more than 20 million Americans1 and 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 patients,2 but it is often under-diagnosed and left untreated. VivAer offers physicians a unique treatment modality that gently remodels tissue in the nasal valve, increasing its ability to resist collapse.
"We believe that one reason NVC is commonly overlooked is the scarcity of non-invasive treatment options as an alternative to surgical repair," said Scott Wolf, M.D., founder and chief medical officer of Aerin Medical. "To date, more than 30,000 people have been treated with VivAer, and the strong VATRAC trial results reflect our commitment to building a robust body of clinical evidence to support the safety and effectiveness of this non-invasive device."
