VivAer Device May Help Improve Nasal Obstruction With Nasal
Results from the VATRAC trial confirm the safety and efficacy of VivAer for the treatment of nasal airway obstruction (NAO) caused by nasal valve collapse (NVC). The study showed significant improvement in nasal obstruction symptoms in those treated with VivAer compared to the control group. This is the first randomized controlled trial of a non-invasive, radiofrequency treatment of nasal valve collapse (NVC).

VivAer is a non-invasive treatment for nasal airway obstruction due to nasal valve collapse. The study builds on the growing body of evidence that VivAer provides an attractive alternative to traditional surgical procedures for appropriate patients. "The outcome of this study provides one of the highest levels of clinical evidence" to support its use, says co-principal investigator Joseph K. Han.

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 and symptom reduction. 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 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, 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.

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