Nasal airway obstruction (NAO) is a condition characterized by impaired breathing and insufficient airflow through the nasal passages. Structural alterations within the internal nasal anatomy—such as deviations in the turbinates, septum, and/or ostiomeatal complex—can significantly affect an individual’s perception of airflow. NAO commonly arises from a range of mechanical and mucosal causes, with deviated nasal septum being one of the most prevalent conditions; however, the underlying pathophysiology is often multifactorial. There is currently no universally accepted standard for quantifying the degree of nasal obstruction, as objective assessments (e.g., acoustic rhinometry, peak nasal airflow, rhinomanometry) may not correlate with subjective symptoms. Instead, clinicians rely on a combination of patient-reported outcomes (e.g., the Nasal Obstruction Symptom Evaluation [NOSE] score) alongside medical history and physical examination.
Septoplasty, rhinoplasty, or septorhinoplasty are surgical procedures that may be performed to correct NAO. Septoplasty corrects defects or deformities of the nasal septum by altering, splinting, or removing obstructive supporting structures. Septoplasty is often performed as a stand-alone surgery to restore function and improve airflow through the breathing passages. Rhinoplasty changes the shape and size of the nose. Incisions are made, and parts of the underlying bone and cartilage may be removed, added to, or rearranged to provide a newly shaped structure. The tissues are then placed over the new frame, and the incisions are closed. Postoperatively, a splint is used to retain the new shape of the nose as it heals. Absorbent packing and soft nasal supports may be placed inside the nose to maintain stability along the septum or divide the walls of the airways. A reconstructive rhinoplasty restores function or corrects a structural nasal deformity due to trauma and/or accident (e.g., nasal fracture), disease (e.g., tumor, infection), or congenital defect (e.g., congenital cleft lip, cleft nose, and/or palate). Although reconstruction is typically performed to improve function, it may also be done to approximate a more normal-looking appearance. A cosmetic rhinoplasty or septoplasty reshapes normal nasal structures that have no functional deficits in order to aesthetically enhance an individual's appearance. Cosmetic services are those provided to improve an individual's physical appearance, from which no significant improvement in physiologic function can be expected. Emotional and/or psychological improvement alone does not constitute improvement in physiologic function. When septoplasty is performed during the same operative session as rhinoplasty (for either cosmetic or reconstructive purposes), the entire procedure is referred to as septorhinoplasty.
Dermabrasion is a form of skin resurfacing used to remove damaged skin and promote normal wound healing and skin rejuvenation. Standard dermabrasion uses a wire brush or a stainless steel wheel on which diamond chips have been bonded (diamond fraise) abraders to plane the skin whereas laser dermabrasion involves use of the argon laser, ultrapulse carbon dioxide (CO2) laser, or flashlamp-pumped pulsed dye laser. Dermabrasion is used for the treatment of many different dermatological conditions such as acne scars, wrinkles, and different forms of rosacea. The treatments of these conditions are considered cosmetic as they are usually not associated with any functional impairment or deformities. Rhinophyma is characterized by skin thickening, which can cause an enlargement of the nose due to excess tissue and overgrowth of sebaceous glands. Rhinophyma may pose functional problems such as nasal airway obstruction, including sleep apnea. The treatment of this condition is to remove the hypertrophic skin. There are several different procedures used to treat rhinophyma but there is not a consensus of a gold standard treatment.
TEMPERATURE CONTROLLED RADIOFREQUENCY (TCRF) DEVICES (E.G., VIVAER SYSTEM)
TCRF devices are used in a noninvasive office-based procedure as an alternative to invasive surgical interventions. VivAer (Aerin Medical Inc.), is a type of TCRF device intended to modify the soft tissue of the nasal airway using low-dose nonablative radiofrequency (RF) energy for the treatment of nasal valve collapse (NVC). The RF energy can be used to remodel nasal cartilage and soft tissue throughout the nasal valve, including the septum, the inferior turbinate, and the nasal valve itself. Current standard practice for individuals with severe to extreme nasal airway obstruction (NAO) who have exhausted conservative therapies (e.g., medication, stents) is typically surgery. TCRF was introduced as a less invasive option for similar indications.
Due to the lack of standardization regarding objective clinical outcome measures for diagnosing NAO, patient-reported measures (e.g., nasal obstruction symptom evaluation [NOSE]) are often the gold-standard for understanding intervention efficacy before and after the procedure. The NOSE scale differentiates severity into the following categories: Mild (5-25), moderate (30-50; NAO threshold), severe (55-75), and extreme (80-100) (Lipan et al, 2013). A moderate or higher score is associated with difficulty performing daily activities (e.g., sleeping, congestion, trouble breathing when sitting or exercising). Individuals may be indicated for further treatment if they have a moderate or greater score, considering these individuals have difficulty performing activities of daily living (e.g., sleeping, congestion, trouble breathing when sitting and/or exercising).
Outcomes essential for determining treatment efficacy when patient-reported scores are the primary endpoint, include measuring the mean change in NOSE score from baseline, as well as the minimum clinically important difference (MCID). The MCID is needed for assessing the extent of a clinically meaningful treatment effect from a population standpoint, representing the smallest change in an outcome that clinicians or patients would perceive as significant.
SUMMARY OF VIVAER EVIDENCE
The aggregate literature using VivAer for the treatment of NAO appears to demonstrate some meaningful change from baseline using relevant outcomes of interest. Nevertheless, significant limitations in the evidence remain that are not adequately addressed in recent literature. For example, Yao et al (2023 & 2025) showed NOSE score improvement sustained up to 3-years, but high attrition and no sham or head-to-head comparator preclude conclusions on any potential long-term benefit from TCRF. One study attempted to mitigate this limitation by incorporating a sham control (Silvers et al., 2021 & 2024; Han et al., 2022 & 2025). Treatment efficacy was demonstrated over the sham group up to 3-months; however, the sham cross-over after 3-months gives pause to the durability of VivAer, regardless of any subsequent follow-up periods. Han et al. (2024) tried to address these limitations in a systematic review and meta-analysis using a matched comparator, but the indirect nature of the controls, combined with substantial variability within the study groups, limits confidence in both the long-term efficacy findings and how the device measures up to established treatments. At this time, there are no randomized control trials that make a direct comparison of VivAer to current surgical interventions, nor long term sham-controlled trials. In consideration of the overall limitations, the available literature for VivAer is unable to establish safety and efficacy and fails to meet the clinical gap in the current standard of care.
EVIDENTIARY REVIEW OF VIVAER
Although there are other TCRF devices, VivAer by Aerin Medical is the only device with FDA approval for the treatment of nasal valve collapse. Preferred studies considered for analysis are systematic review and meta-analyses and randomized controlled trials. Prospective single-arm clinical trials and case reports/series may be considered to supplement the available evidence.
Yao et al (2025) conducted a prospective, single-arm trial in 122 individuals diagnosed with NAO (i.e., severe to extreme NOSE score [≥ 55]). Mean baseline NOSE score was 80.3 (95% CI, 78.1 to 82.6). The initial study by Yao et al. (2023) documented five total timepoint measurements (i.e., Baseline, 3-month, 6-month, 1 year, 2 years) with a primary outcome defined as procedure responders (i.e., individuals with ≥ 20% improvement in NOSE Scale score or ≥ 1 severity-class improvement from baseline). Unlike previously reported populations in TCRF trials, the authors include and provide analysis for subpopulations such as septal deviation/turbinate, turbinate hypertrophy, nasal polyps, and nasal vestibular stenosis. The latest evidence provides an extended 3-year follow-up of 66 individuals. The primary outcome was change in NOSE score from baseline. The adjusted mean NOSE score at 3-years was 35.1 (95% CI, 27.8 to 42.3; P < 0.001) representing a mean change of -45.3 (95% CI, -54.2 to -36.4; P < 0.001). This score improvement is similar to results at previously documented timepoints. Akin to the previous study, medication use was significantly reduced or stopped completely. No serious adverse events (AE) or device-related AEs were reported at the 36-month follow-up. There are some substantial limitations that lessen the strength of this study. The author's aim was to establish durability, but the 3-year extension trial was unplanned and provided a different primary endpoint from the initial study (i.e., “Responders" vs. “Non-responders"). Moreover, there was a considerable loss to follow-up, with over 50% of participants leaving the study. Due to the extended follow-up period, changes in primary outcomes from the original study, and a high attrition rate, it is not possible to draw firm conclusions about the long-term durability of VivAer. Future studies may benefit from conducting a head-to-head trial to better appreciate the influence VivAer has on NAO populations compared to the standard of care.
Silvers (2024 & 2021) and Han (2025 & 2022) performed a prospective, multicenter, single-blinded, randomized controlled crossover trial with 77 in the treatment cohort and 41 in the sham control group. Follow-up assessments were scheduled for three, 12, and 48 months, with an additional extended evaluation planned at the 3-year mark. Individuals had a baseline mean NOSE scale score ≥ 55 (VivAer: 76.7 vs. Control: 78.8) and responders were defined as ≥ 20% decrease in NOSE score from baseline. At 3-months, the active treatment group had a significantly greater responder rate (88.3% vs. 42.5%; P < 0.001) as well as a larger mean change in NOSE score (-42.3 vs. -16.8; P < 0.001) compared to the sham cohort. Participants in the treatment group achieved a mean NOSE score of 27.9 (95% CI, 22.3 to 33.5), indicating substantial symptomatic improvement, whereas majority of the sham control remained severely symptomatic. The authors also performed a post-hoc analysis stratified by nasal valve collapse (NVC) diagnosis (i.e., bilateral static, dynamic, and static/dynamic, as well as complex [one nostril static and one nostril dynamic and unilateral static/dynamic]). Baseline NOSE scores were comparable across all groups; however, the bilateral collapse groups demonstrated a significant improvement compared to the sham, highlighting VivAer’s adaptability in addressing diverse NVC subtypes. After the primary end-point evaluation at 3 months, eligible individuals in the sham control crossed over to the active treatment group. At 12 months, the responder rate was 89.8% (95% CI, 81.7%–94.5%), and the mean NOSE score change continued to improve from baseline (−44.9 [95% CI, −52.1 to −37.7 After two years, the responder rate in the treatment cohort (n=73) was sustained (90.4% [95% CI, 81.5% to 95.3%]) from the three month timepoint (86.0% [95% CI, 78.2% to 91.3%]). They also showed sustained NOSE score treatment effect through two years (-41.7 [95% CI -48.8 to -34.6]) from the three month timepoint (adjusted mean, -40.9 [95% CI, -46.9 to -35.0]). The treatment continued to remain beneficial up to the 3-year extended follow-up. The NOSE responder rate was 87%, with an adjusted mean NOSE score of 27.1 (95% CI, 20.4 to 33.8) and mean difference of -49.5 (95% CI, -56.6 to -42.4; P < 0.001). Medication, though not dictated by the trial protocol, was also assessed through three years where an overall trend in medication reduction or discontinuation was documented. While concomitant medication reflects real-world clinical outcomes, the treatment's effectiveness may be overestimated. Additional limitations include high attrition rate at 3-years (50%) and the lack of comparative long-term outcomes. Despite demonstrated efficacy up to three months compared to the sham cohort, the lack of long-term comparison precludes an ability to determine the treatment’s sustained safety and efficacy. Future studies with extended follow-up of the sham cohort are needed to determine the clinically meaningful impact of VivAer in the NAO population.
Kang and colleagues (2023) conducted a systematic review and meta-analysis of eight studies totaling 451 participants receiving TCRF treatment. The study assessed NOSE scores before and after VivAer at varying time points (i.e., 1, 3, 6, 12, 18, and 24- months). All timepoints demonstrated improved NOSE scores, with months 6, 12, 18, and 24 showing the greatest improvement (mean difference, 6-month: 52.37, 12-month: 50.73, 18-month: 49.85, and 24-month: 56.35). Only the 24-month post-treatment period had a significant improvement from baseline (P = 0.0107). Upon further review of individual studies, a major limitation is the use of identical clinical trials for the same timepoint when analyzing change in NOSE scores. This duplication of data skews the sample size for timepoints 6, 12, 18, and 24-months and may reflect inaccurate statistical significance, particularly with the 24-month timepoint. Regardless, without long-term follow up using a sham or alternative comparator, the efficacy and durability of TCRF cannot be determined based on the reviewed literature.
ABSORBABLE NASAL IMPLANT SYSTEM (E.G., LATERA)
Latera received FDA clearance via the 510(k) pathway in 2016. It is a bioabsorbable nasal implant designed to reinforce cartilage in the nasal lateral wall, addressing dynamic nasal valve collapse—a condition where the nasal valves collapse during inhalation. Latera can be inserted unilaterally or bilaterally. The implant is primarily cylindrical, measuring 1 mm in diameter and 24 mm in length, with a forked distal end that anchors to the maxillary periosteum. It is made from a poly (l-lactide-co-d-l-lactide) 70:30 copolymer, which is gradually absorbed by the body over approximately 18 months. Latera provides a minimally invasive alternative for those seeking to avoid more extensive surgical procedures.
SUMMARY OF LATERA EVIDENCE
The body of evidence on Latera for individuals with dynamic nasal valve collapse primarily comprises single-arm prospective studies evaluating outcomes before and after treatment. While these studies suggest improvements in nasal function across a large number of participants, the absence of a comparator—such as a sham procedure or standard care—limits the ability to assess the device’s true clinical impact. To address this gap, one randomized controlled trial compared Latera treatment to a sham control over a 3-month period. However, significant improvements in patient-reported outcomes in both groups raise concerns about potential placebo effects, where the perception of receiving treatment alone may have contributed to symptom relief. Future research would benefit from sham-controlled trials with extended follow-up beyond three months to more robustly evaluate Latera as a viable, minimally invasive option for treating nasal valve collapse.
EVIDENTIARY REVIEW OF LATERA
The evidence surrounding Latera is a single systematic review and meta-analysis encompassing all published literature to date.
Kim et al. (2020) performed a systematic review and meta-analysis to assess the efficacy of Latera bioabsorbable nasal implant for the treatment of nasal valve collapse. Endpoints evaluated were quality of life measures, such as NOSE and visual analog scale (VAS) scores. Pre- and post-treatment scores were compared up to 12 months. Mean pre- and post-treatment NOSE scores at all timepoints demonstrated significant improvement. VAS scores also showed significant improvement at all follow up timepoints. The sham-controlled trial showed significant improvement in NOSE and VAS symptoms among the sham cohort at 3-months; however, when compared to the treatment group, bioabsorbable implants presented greater effectiveness (NOSE Mean Difference [MD] between cohorts -20.00 points; VAS MD -20.30). Most studies to date have been single-arm prospective trials assessing pre- and post-treatment outcomes. Although these findings suggest improvements in nasal function, the absence of a comparator limits conclusions about the device’s true clinical impact. To address this gap, a randomized sham-controlled trial evaluated individuals with nasal valve collapse over a 3-month period. However, significant improvements in NOSE and VAS scores in both groups indicate potential placebo effects. Additional sham-controlled studies with longer follow-up are needed to strengthen the evidence base for Latera as a treatment for nasal valve collapse.
