Evaluate the Effectiveness of the Vivaer ARC Stylus for Nasal Breathing

The primary efficacy endpoint is the responder rate at 3 months after the procedure for the participants.

Individual participant success (responder) is defined as at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class improvement or an improvement (decrease) in NOSE score of 20% or more from baseline at the 3-month evaluation.

Efficacy measurement using the change in mean NOSE SCORE from baseline to the 3-month evaluation.

The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity.

Safety Control regarding the frequency of device-related and procedure-related adverse events.

All adverse events will be analyzed for all participants. Adverse events will be coded using a custom Aerin Medical dictionary so that adverse events may be categorized for analysis at an appropriate level of detail. Listings will be provided to detail individual events. The number of participants, number of AEs, and the proportion of participants reporting each AE will be summarized. Seriousness and severity of AEs and their relationship to the device and procedure will be summarized. A time course of adverse events will be presented. Any unexpected adverse device experiences or adverse events that occur at an unexpectedly high incidence rate will receive detailed analyses. Narratives will be presented for all deaths, serious adverse events, unexpected adverse device experiences, and participants withdrawn due to an adverse event.

Incidence (type and category) of adverse events overall and by follow-up interval.

The target nasal valve area within each nostril will be visually assessed at baseline and following the treatment procedure at all evaluations. The use of an endoscope for visual assessment is required. Representative still photographs or video of each nostril will be captured at each visit.

Self-reported assessment of an increase, no change, or decrease in medications and/or devices being used for treatment of nasal symptoms at each evaluation compared to use prior to the procedure.