Clinical UM Guideline

This document addresses the use of balloon sinus ostial dilation for surgery of the sinuses, including for the treatment of sinusitis. These procedures involve insertion of a balloon catheter device into a nasal sinus cavity to open blocked sinus ostia.

Note: Please see the following related documents for additional information:

• CG-SURG-18 Septoplasty
• CG-SURG-24 Functional Endoscopic Sinus Surgery (FESS)
• CG-SURG-57 Diagnostic Nasal Endoscopy
• CG-SURG-117 Balloon Dilation of the Eustachian Tubes
• SURG.00089 Self-Expanding Absorptive Sinus Ostial Dilation
• SURG.00132 Drug-Eluting Devices for Maintaining Sinus Ostial Patency

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Note: When Functional Endoscopic Sinus Surgery (FESS) is performed in conjunction with a procedure addressed in this document, the criteria contained in CG-SURG-24 must be met for the FESS procedure.

Medically Necessary:

The use of balloon sinus ostial dilation is considered medically necessary when all of the following criteria have been met (A, B, C, and D):

1. Treatment is for uncomplicated sinusitis (for example, sinusitis confined to the paranasal sinuses without adjacent involvement of neurologic, soft tissue, or bony structures); and
2. Either of the following:
   1. Four or more documented episodes of acute rhinosinusitis (ARS) (for example, ARS episodes up to 4 weeks duration) in 1 year; or
   2. Chronic sinusitis (for example, greater than 12 weeks duration);
      and
3. Maximal medical therapy has been attempted, as indicated by all of the following:
   1. Antibiotic therapy; and
   2. Trial of inhaled steroids; and
   3. Nasal lavage; and
   4. Allergy testing (if symptoms are consistent with allergic rhinitis and have not responded to appropriate environmental controls and pharmacotherapy [for example, antihistamines or intranasal corticosteroids or leukotriene antagonists, etc.]);
      and
4. Abnormal findings from diagnostic work-up, as indicated by any one of the following:
   1. Computed tomography (CT) findings suggestive of obstruction or infection (for example, but not limited to, air fluid levels, air bubbles, significant mucosal thickening, pansinusitis, or diffuse opacification); or
   2. Nasal endoscopy findings suggestive of significant disease; or
   3. Physical exam findings suggestive of chronic/recurrent disease (for example, mucopurulence, erythema, edema, inflammation).

Not Medically Necessary:

The use of balloon sinus ostial dilation is considered not medically necessary in all other circumstances not stated above, including the following:

1. The criteria above have not been met; or
2. The individual has been diagnosed with presence of sinonasal polyposis; or
3. The procedure is being used to treat the following conditions in the absence of CT-confirmed chronic sinusitis or recurrent acute sinusitis:
   1. Headache; or
   2. Sleep apnea.

This document describes clinical studies and expert recommendations, and explains whether balloon sinus ostial dilation procedures are clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Balloon sinus ostial dilation is a procedure used to treat certain types of long-term or repeated sinus infections. It uses a small balloon device that is placed through the nose into the sinus opening, where it is inflated to widen the passage and help mucus drain. This can be done instead of, or along with, more traditional types of sinus surgery. Many people have fewer symptoms and shorter recovery times after balloon dilation. It may also reduce the need for pain medicine or follow-up procedures.

What the Studies Show

Balloon sinus dilation has been studied for more than a decade. Some research shows that people who had this procedure felt better and had fewer sinus problems afterward. Compared to standard sinus surgery, balloon dilation may cause less bleeding and pain, and allow people to return to normal activities sooner. Some studies also found that fewer follow-up visits were needed. In some studies, the balloon method and traditional surgery helped people equally. However, many of the studies have limitations. Some included only a small number of people, did not compare the balloon method to other treatments, or did not track results for long enough to judge if the results last over time. Some studies were funded by companies that make the devices, which could have influenced how results were interpreted. Experts agree that this method can be useful for selected people, but more high-quality research is needed to better understand how well it works in situations other than those listed below.

When is Balloon Sinus Ostial Dilation Clinically Appropriate?

Balloon sinus ostial dilation may be appropriate in these situations:

• The person has uncomplicated sinusitis (not spreading to other areas); and
• Either:
  • Has had 4 or more short-term sinus infections in the past year; or
  • Has had sinusitis lasting longer than 12 weeks; and
• Medical treatment has already been tried, including:
  • Antibiotics; and
  • Inhaled steroid medicines; and
  • Nasal rinses; and
  • Allergy testing and treatment if allergy symptoms are present and not improved with usual allergy care; and
• There are signs of sinus disease, based on:
  • Nasal exam showing disease; or
  • Physical exam showing signs like redness, swelling, or pus in the nose; or
  • CT scan findings such as fluid buildup or blocked sinuses.

When is this not Clinically Appropriate?

Balloon sinus ostial dilation is not appropriate in these situations:

• If the above criteria are not met; or
• The person has nasal polyps (growths in the nose); or
• The person is being treated for headache or sleep apnea without clear signs of chronic or frequent sinus infections on a CT scan.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met or for all other diagnoses including, but not limited to the following:

Summary:

Chronic rhinosinusitis (CRS) is a persistent inflammatory condition of the paranasal sinuses characterized by prolonged or recurrent symptoms, often associated with impaired sinus drainage due to factors such as allergies, anatomic obstruction, or infection. Unlike acute sinusitis, CRS is typically multifactorial and may involve chronic inflammation, mixed microbial colonization, and structural abnormalities. Clinical manifestations may be less severe than acute disease but can lead to ongoing mucosal damage and reduced quality of life. Initial management is medical using intranasal corticosteroids, saline irrigation, and selective use of antibiotics when bacterial infection is evident. Surgical intervention is considered for individuals with persistent symptoms despite appropriate medical therapy, particularly when there is objective evidence of disease on nasal endoscopy or computed tomography (CT).

Endoscopic sinus surgery (ESS) remains the standard surgical approach, allowing direct visualization and enlargement of sinus outflow tracts. Balloon sinus ostial dilation (balloon sinuplasty) has emerged as a less invasive alternative or adjunct, using catheter-based dilation to restore sinus drainage. Evidence suggests that, in appropriately selected individuals, balloon dilation provides symptom improvement comparable to ESS with potential advantages including shorter operative time, reduced postoperative discomfort, and fewer debridement requirements, though long-term durability remains less certain. Specialty society guidelines support the use of balloon dilation in selected individuals with CRS or recurrent acute rhinosinusitis (RARS) who have failed medical therapy and demonstrate objective evidence of disease, while emphasizing that individual selection, imaging confirmation, and individualized treatment planning are essential to optimize outcomes.

Discussion

CRS is a prolonged or recurrent infection and inflammation of the nasal sinuses. Nasal sinuses are open spaces in the head connected by small passageways to the nasal passageways leading from the nose. Under normal conditions, air passes in and out of the sinuses and mucus and fluid drain from the sinuses into the nose. Sinusitis occurs when there is infection or inflammation in one or more of the sinuses. Temporary or acute sinusitis is often associated with upper respiratory infections or irritation due to allergic reactions which cause temporary blockage of the passages leading from the sinuses. Blocked sinuses can accumulate nasal secretions and bacteria, leading to infection. CRS is a long-term condition that may develop in people with chronic allergies, deviated nasal septum or other obstruction of the nasal airway. Additionally, dental infections such as tooth abscesses may also spread into the sinus and infect it directly. When sinusitis recurs frequently, or lasts for a prolonged period of time, it is classified as chronic.

ARS is usually caused by infection with a single type of bacteria or virus, CRS is usually caused either by allergies or by infection with a mixture of different types of bacteria. CRS may have less severe symptoms than acute sinusitis but can cause damage and destruction to the tissues of the sinuses. It may flare up spontaneously or may follow respiratory infections such as colds.

Treatment of CRS usually involves the use of antibiotics if the infection is bacterial. Oral sinus decongestants are sometimes used as well. In more serious cases related to allergies, topical steroids in the form of nasal sprays may help in controlling inflammation. Surgery to clean and drain the sinuses may be necessary to clear serious chronic infections. Finally, surgical repair of a deviated nasal septum or other nasal obstruction may prevent recurrence of CRS. Sinus surgery is commonly done with the use of thin fiberoptic tools that are passed through the nostrils. This method, referred to as endoscopic sinus surgery, allows visualization and manipulation of the surgical site without the need for surgical incisions in the mouth or face. Once the endoscopic tools are in place in the surgical site, small tools are used to obliterate the sinus tissue and bone to open the sinus passages.

A technique referred to as balloon sinus ostial dilation has been proposed as an alternative or addition to standard endoscopic surgery. This procedure uses a small balloon-like device placed in the blocked sinus passage under endoscopic guidance through the nostril and inflated to push the sinus tissue and bone out of the way. This creates a larger airway passage allowing drainage of nasal secretions.

The U.S. Food and Drug Administration (FDA) has cleared several devices for the catheterization and balloon dilatation of the paranasal sinus ostia, a procedure known as balloon sinus ostial dilation, for the treatment of CRS. These devices include the Acclarent Relieva^™ Sinus Balloon Catheter (FDA clearance August, 2005 for transnasal use), the Entellus FinESS^™ device (FDA clearance June, 2008 for transantral use), the Entellus XprESS^® Multi-Sinus Dilation Tool (FDA clearance September, 2010 for transnasal use), the NuVEnt^™ EM Sinus Dilation System (FDA clearance July, 2013 for transnasal use), and the Ventera^® Sinus Dilation System (FDA clearance 2012 for transnasal use). In 2020, the Next Generation Balloon Dilation System (Acclarent, Inc., Irving, CA), an integrated balloon sinuplasty and eustachian tube dilation device, received 510(k) clearance. Balloon Sinuplasty^™ is a trademarked term describing transnasal use of the Acclarent Relieva Sinus Balloon Catheter.

Specialty Society Recommendations

In 2017, the American Academy of Otolaryngology Head and Neck Surgery (AAO-HNS) endorsed a position statement addressing the use of balloon dilatation. The statement says:

Sinus ostial dilation is a therapeutic option for selected patients with chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis (RARS) who have failed appropriate medical therapy. Clinical diagnosis of CRS and RARS should be based on symptoms of sinusitis and supported by nasal endoscopy documenting sinonasal abnormality and evidence of mucosal thickening on computed tomography of the paranasal sinuses. This approach may be used alone to dilate an obstructed sinus ostium (frontal, maxillary, or sphenoid) or in conjunction with other instruments ([for example], microdebrider, forceps). The final decision regarding use of techniques or instrumentation for sinus surgery is the responsibility of the attending surgeon.

The AAO-HNS also published a clinical consensus statement on balloon dilation of the sinuses which included the following statements that achieved consensus (Piccirillo, 2018):

• Balloon dilation is not appropriate for patients who are without both sinonasal symptoms and positive findings on CT.
• Balloon dilation is not appropriate for the management of headache in patients who do not otherwise meet the criteria for chronic sinusitis or recurrent acute sinusitis.
• Balloon dilation is not appropriate for the management of sleep apnea in patients who do not otherwise meet the criteria for chronic sinusitis or recurrent acute sinusitis.
• CT scanning of the sinuses is a requirement before balloon dilation can be performed.
• Balloon dilation is not appropriate for patients with sinonasal symptoms and a CT that does not show evidence of sinonasal disease.
• Balloon dilation can be appropriate as an adjunct procedure to FESS in patients with chronic sinusitis without nasal polyps.
• There can be a role for balloon dilation in patients with persistent sinus disease who have had previous sinus surgery.
• There is a role for balloon sinus dilation in managing patients with recurrent acute sinusitis as defined in the AAO-HNSF guideline based on symptoms and the CT evidence of ostial occlusion and mucosal thickening.

In 2021, the AAO-HNS reaffirmed their position statement regarding the use of balloon sinus dilatation, the recommendations remain unchanged.

In 2023, the American Rhinologic Society (ARS) published an updated position statement on ostial balloon dilation. This document reiterated the ARS’s support for the use of sinus ostial dilation as a therapeutic option for selected individuals with CRS and RARS who have failed appropriate medical therapy.

In June 2025, AAO-HNS published the Surgical Management of Chronic Rhinosinusitis Clinical Practice Guideline (CPG) which defined conditions related to rhinosinusitis (see Definitions section) and provided the following relevant recommendations:

Statement 1: Verification of Diagnosis and Assessment of Candidacy for Surgery
1A: The surgeon should verify an existing diagnosis of CRS to ensure established diagnostic criteria (signs and symptoms) from CPGs are met
AND
1B: The surgeon should assess candidacy for sinus surgery based on symptoms, disease characteristics, QOL, and prior medical or surgical therapy.
Evidence strength: Strong recommendation based on multiple CPGs and SRs.

Statement 2: No One-Size-Fits-All Regimen
The surgeon should not endorse or require a predefined, one‐size‐fits‐all regimen or duration of medical therapy (eg, antibiotics, steroids, antihistamines) as a prerequisite to sinus surgery for an adult with CRS.
Evidence strength: Recommendation based on RCTs and meta‐analyses that show variable quality in the types of medical therapeutics for the treatment of CRS.

Statement 3: Assessment Before Prescribing Antibacterial Therapy
The surgeon or their designee should not prescribe antibacterial therapy to an adult with CRS if significant or persistent purulent nasal discharge (anterior, posterior, or both) is absent on examination.
Evidence strength: Strong recommendation based on RCTs that are limited in number but demonstrate a preponderance of benefit over harm when limiting the indiscriminate use of antibiotics for CRS treatment.

Statement 4: Relative Benefits of Surgery or Medical Therapy Alone
The surgeon should identify patients with CRS that would benefit most from surgery and are least likely to benefit from continued medical therapy alone, such as those with CRS subtypes that include, but are not limited to, CRS with polyps, polyps with bony erosion, eosinophilic mucin, or fungal balls.
Evidence strength: Recommendation based on a limited number of RCTs and multiple observational studies that demonstrate consistent benefit over harm through avoidance of delays in care and disease progression when timely surgery is provided as part of an overall care plan; insufficient equipoise to pursue trials comparing medical therapy alone and surgery in cases of CRS with skull base erosion, eosinophilic mucin rhinosinusitis, allergic fungal rhinosinusitis (AFRS), or fungal ball due to concerns about disease progression and harm to surrounding anatomic structures.

Statement 5: Patient Education About Surgery and Long-Term Management
The surgeon or their designee should counsel patients before sinus surgery to establish realistic expectations, including the potential for chronicity or relapse, and the likelihood of long‐term medical management, taking into account their CRS subtype.
Evidence strength: Recommendation based on moderate quality evidence (levels B and C).

Statement 6: When to Offer Sinus Surgery
The surgeon should offer sinus surgery to an adult with CRS when the anticipated benefits exceed that of nonsurgical management alone, there is clarity regarding the anticipated outcomes, and the patient understands the expectation for long‐term disease management following surgery.
Evidence strength: Recommendation based on cohort studies and one RCT that support a preponderance of benefit over harm.

Statement 7: Imaging in Candidates for Sinus Surgery
For an adult who is a candidate for sinus surgery, the surgeon or their designee should obtain a CT scan with a fine‐cut protocol, if not already available, to examine the paranasal sinuses for surgical planning.
Evidence strength: Recommendation based on limited and mostly observational reports, surgeon preference, and availability of imaging with a majority of evidence of moderate quality and moderate correlation with surgical outcomes.

Statement 8: Avoid Arbitrary Criteria for Mucosal Thickening
The surgeon should not plan the extent of sinus surgery (eg, which specific sinuses to operate on) solely based on arbitrary criteria regarding a minimal level of mucosal thickening, sinus opacification, or outflow obstruction on a CT scan.
Evidence strength: Recommendation based on a preponderance of benefit over harm.

In 2025 the AAO-HNS published a Debridement Position Statement that supports sinonasal debridement as an adjunctive postoperative intervention following ESS, emphasizing its role in promoting mucosal healing and maintaining patency of the sinonasal cavities. Debridement facilitates removal of crusting, debris, and fibrinous material, thereby reducing synechiae formation and optimizing surgical outcomes. AAO-HNS notes that the recommended frequency of postoperative debridement is individualized and should be based on clinical factors including disease severity, comorbid conditions, adherence to intranasal care, and wound healing status. In typical postoperative courses, one to three debridement procedures are sufficient; however, additional sessions may be warranted in individuals with more severe disease, impaired healing, or increased risk of scar formation. Appropriate postoperative debridement is associated with reduced adhesion formation and may decrease the likelihood of revision endoscopic sinus surgery.

Clinical Evidence

Early evidence on balloon sinus dilation consisted primarily of small, uncontrolled case series with short-term follow-up, often less than 6 months. Given that chronic rhinosinusitis is a persistent condition, these timeframes are insufficient to determine durability of benefit. Even when longer follow-up was reported, studies frequently lacked concurrent control groups, randomization, or blinding, limiting causal inference. Across these early studies, improvements in patient-reported outcomes (for example, sino nasal outcome test SNOT-20 scores) and high ostial patency rates were commonly reported, but these findings relied heavily on subjective measures and were limited by incomplete follow-up data.

The CLEAR study (Bolger, 2007; Kuhn, 2008; Weiss, 2008) and BREATHE I trial (Stankiewicz, 2009, 2010, 2011, 2012) exemplify these limitations. Both were prospective multicenter case series reporting symptom improvement, low complication rates, and high short-term patency. Some durability of symptom improvement was observed up to 1-2 years. However, these studies were unblinded, lacked control groups, and were subject to significant loss to follow-up and reliance on self-reported outcomes.

Similarly, larger case series such as ORIOS 2 (Karanfilov, 2012; Sikand, 2015) and other observational studies (Albritton, 2012; Brodner, 2013; Friedman, 2008; Heimgartner, 2011; Levine, 2008; Tomazic, 2013) reported favorable symptom and radiographic outcomes with low revision rates, but shared the same methodological concerns, including selection bias, short follow-up, and absence of comparative data.

Randomized controlled trials provide somewhat stronger evidence but remain limited. The Plaza (2011) double-blind randomized controlled trial (RCT) (Plaza, 2011; Lefevre, 2012; Plaza, 2012) and the Hathorn (2014) single-blind split-body RCT (Hathorn, 2014) found no significant differences between balloon dilation (or hybrid approaches) and standard functional endoscopic sinus surgery (FESS) in objective outcomes such as CT findings or ostial patency. However, both trials were small, had methodological inconsistencies (including unclear randomization and reporting errors), and were not powered to establish equivalence or superiority.

The REMODEL trial (Cutler, 2013; Bikhazi, 2014; Chandra, 2015) is the most robust study, a quasi-blinded non-inferiority RCT comparing balloon dilation to FESS. It demonstrated similar improvements in symptom scores between groups through 6-18 months, with some advantages for balloon dilation in perioperative outcomes (for example, fewer debridements, less pain medication use, and faster recovery). However, follow-up beyond 1 year was marked by substantial attrition (nearly 90% at 2 years), significantly limiting conclusions about long-term durability. The accompanying meta-analysis (Chandra, 2015) similarly reported significant symptom improvement across pooled studies but was largely based on uncontrolled trials with short follow-up.

Overall, the body of evidence suggests that balloon sinus dilation may improve short-term symptoms and has a favorable safety profile. Strengths include consistent reporting of symptom improvement and low complication rates across studies. However, the evidence is limited by small sample sizes, lack of rigorous controls in many studies, reliance on subjective outcomes, and insufficient long-term follow-up. As a result, the durability of benefit and comparative effectiveness relative to established surgical approaches could not be ascertained by these older studies.

In 2016, Payne reported the results of a prospective, multicenter, nonrandomized comparative study of 198 individuals with CRS. Participants self-selected to receive continuing medical management (n=52) or balloon ostial dilation (n=146) and were followed for 24 weeks post-procedure. The medical management regimen was not standardized and was left to the discretion of the treating physician. The balloon procedures were done either in the operating room (n=41) or in the office (n=105), again at the discretion of the treating physician and could include adjunctive procedures. The study was stopped early after an interim analysis suggested superiority of the balloon procedure. Technical success of the dilation procedure was reported to be 97.6%. At 24 weeks, improvements in disease-specific quality of life measures (SNOT-20, Rhinosinusitis Disability Index [RSDI], and Chronic Sinusitis Survey [CSS]) were all statistically better in the balloon group (p=0.002, p<0.001, and p=0.001, respectively). While these findings suggest greater short-term improvement with balloon dilation compared with continued medical management, interpretation is limited by important methodological concerns. These include nonrandomized treatment allocation with patient self-selection (introducing selection bias), lack of blinding, heterogeneous and nonstandardized medical therapy, inclusion of adjunctive surgical procedures, crossover from the medical management group, reliance on subjective outcome measures, and relatively short follow-up for a chronic condition.

Koskinen (2016) published the results of a retrospective-prospective, nonrandomized or blind controlled trial involving 208 individuals older than 13 years of age with bilateral maxillary sinus disease who underwent either FESS involving bilateral partial uncinectomy and middle meatal antrostomy (n=105) or balloon sinus dilation of the maxillary sinuses with the Relieva device (n=103). Participants were identified through record review and contacted by phone at a mean of 6 years for FESS participants and 6.4 years in the balloon group. The phone interview involved a questionnaire addressing the individual’s medical history, smoking habits, occupational exposure, family history, number of sinusitis episodes in the past year, use of nasal steroids, and recent nasal lavage treatments. The FESS group began the study with significantly lower Lund-Mackay scores on the right side. The authors reported that the number of episodes of acute sinusitis, thick nasal discharge and right sided nasal blockage were significantly improved in the FESS group compared to the balloon group. However, no differences were found in nasal symptom score (p>0.05). No significant differences between groups were reported with regard to maxillary lavage or antibiotic courses for acute sinusitis. The overall number of individuals-reported episodes of acute sinusitis were significantly decreased in the FESS group (p<0.01). Revision procedures were conducted in 4 balloon group participants and no FESS group participants (p=0.048).

Chaaban (2018) reported the results of a retrospective cohort study involving data from the Clinformatics Data Mart (CMD) database involving data from 16,040 participants aged 7 to 65 years diagnosed with CRS and treated with FESS alone (n=11,955), balloon sinus dilation alone, (n=2,851) or hybrid FESS-balloon sinus dilation (n=1,234) procedures. Data from 2012-2014 were analyzed. They reported that during the first postoperative 6 months the balloon-only group had a complication rate of 5.26% compared to 7.35% for FESS-only group (no p-values provided). Revision rates for the same timeframe were 7.89% for the balloon-only group, 16.5% for the FESS-only group and 15.5% for the hybrid group (no p-values provided). The authors reported that FESS was associated with an almost 4-fold increase in risk of revision procedures (OR, 3.8). Complications included orbital complications (2.95% in the balloon-only group vs. 3.47% in the FESS-only group), bleeding (2.03% vs. 3.46%, respectively), and skull base/CNS complications (0.35% vs. 0.39%, respectively). Skull base injuries included pneumocephalus and CSF leaks. The rate of secondary procedure was 0.91% for balloon-only compared to 1.40% for FESS-only individuals. The authors concluded, despite the low overall risk, major complications do occur with balloon-only procedures, including cerebrospinal fluid leak, pneumocephalus, orbital complications, and severe bleeding.

Long term results from the Payne (2016) mentioned above were reported by Stolovitzky in 2018. At 52 weeks data were available for 122 (83.6%) of balloon group individuals and 27 (51.9%) of the control medical management group. Improvements in SNOT-20 symptom score, RSDI, and Chronic Sinusitis Survey (CSS) measures were all significantly better in the balloon group (p=0.023, p=0.003, and p=0.001, respectively). As with the other studies described above, the findings reported by Payne indicate significant benefit to the balloon procedure. However, as noted above these findings are impaired by the weak methodology utilized, as well as significant loss to follow-up in both the experimental and control groups.

Another study reported by Kutluhan (2020) described a split-face randomized controlled study involving 61 individuals with mild to severe CRS. Individuals with bilaterally consistent mild/mild (Lund-Mackay score ≤ 6) or severe/severe (Lund-Mackay score ≥ 7) CRS had each side randomly treated with Balloon-only of FESS-only procedures. Follow-up occurred between 13 and 17 months. The results indicated that overall, there were no significant differences in Lund-Mackay scores between the balloon and FESS groups (p=0.24). Similarly, no significant differences in Lund-Mackay scores were reported between treatment groups in individuals with mild CRS (p=0.63). For individuals with severe disease, Lund-Mackay scores were significantly better in the FESS group (p=0.01). The authors concluded that for mild CRS, balloon and FESS procedures provide similar outcomes. However, as CRS severity increases the efficacy of balloon procedures decreases.

Higgins (2020) reported a prospective study (2012-2017) that assessed 35 participants with CRS without nasal polyps who underwent in-office balloon sinus dilation (BSD) while on antiplatelet and/or anticoagulant therapy. The study analyzed demographics, surgical procedure details, the types of antiplatelet and anticoagulant therapy used, and pre- and postoperative scores from the SNOT-22, as well as complications. The average improvement in SNOT-22 scores was 9.9, which was statistically significant and greater than the minimal clinically important difference of 8.9. Absorbable nasal packing was applied to 2 participants for immediate post-procedure bleeding. Intraoperative bleeding was linked to the use of aspirin 325 mg and warfarin. Four participants required FESS after discontinuing anticoagulant/antiplatelet therapy for further sinusitis management. There were no systemic complications or significant postoperative bleeding after leaving the office. The authors concluded that in-office BSD is considered a safe alternative to endoscopic sinus surgery for select individuals who cannot stop taking antiplatelet and anticoagulant therapy.

A meta-analysis by Liang (2025) included 14 RCTs compared sinus balloon catheter dilation with FESS for the treatment of CRS. Sinus balloon catheter dilation use was associated with statistically significant improvements in participant-reported outcomes, with lower postoperative SNOT-20 scores (standard mean difference  [SMD],‐0.25; 95% confidence interval [CI], ‐0.42 to ‐0.07; p<0.01; I² = 94%), shorter operative times (odds ratio [OR], ‐5.00; 95% CI, ‐8.08 to ‐1.91; p=0.001; I² = 50%), and a reduced rate of complications (OR, 0.14; 95% CI, 0.08 to 0.26; p<0.01; I² = 65%) compared to FESS. However, there were no statistically significant differences between sinus balloon catheter dilation and FESS in objective radiographic outcomes (Lund-Mackay scores) (SMD, 0.14; 95% CI, ‐0.04 to 0.32; p=0.12; I² = 15%) or revision surgery rates between the 2 groups (OR, 0.51; 95% CI, 0.12 to 2.21; p=0.37; I² = 0%) or rates of revision surgery. Interpretation of these findings is limited by substantial heterogeneity across studies, reliance on subjective outcome measures, and risk of bias in the included trials, including limited blinding. In addition, the reduction in complications was based on a small number of studies and was primarily driven by minor postoperative events. Overall, the evidence suggests that sinus balloon catheter dilation may be associated with reduced perioperative morbidity compared with FESS; however, there is insufficient high-quality evidence demonstrating comparable or superior clinical effectiveness, particularly with respect to objective outcomes and durability of benefit.

Balloon Sinus Ostial Dilation in Children

In 2014, Brietzke and others published a clinical consensus statement regarding the management and diagnosis of pediatric chronic rhinosinusitis (PCRS). The document included three statements, statements 28 through 30, specifically discussing balloon sinuplasty.

Consensus was reached that there was insufficient current evidence to compare balloon sinuplasty to ESS for PCRS (statement 28). Not unexpectedly, the panel subsequently could not reach consensus regarding the effectiveness of balloon sinuplasty in treating PCRS although there was near consensus (mean Likert score = 6.56) regarding the safety of balloon sinuplasty…

Soler (2017) reported the results of a prospective cohort study of 50 (157 sinuses) children (< 21 years of age) with medically refractory, CT-confirmed CRS treated with balloon sinus dilation with the XprESSS Multi-Sinus Dilation system. Children’s parents were asked to complete the Sinus and Nasal Quality of Life Survey (SN-5) and SNOT-22 survey tools at 1, 3, and 6 months postoperatively. Overall follow-up was 99%. The SNOT-22 tool was only given to participants greater than or equal to 12 years old. A total of 157 sinus dilations were attempted (98 maxillary, 30 frontal, and 29 sphenoid sinuses). The authors reported that all attempts (100%) were successful with no complications noted. Bilateral treatment was conducted in 92% of individuals. Concurrent procedures were conducted in 30 individuals, including adenoidectomy (n=21), inferior turbinate reduction (n=13), and ethmoidectomy (n=6). No serious adverse events or revision procedures were reported. Significant improvements were reported on the SN-5 tool for all individuals at 6 months compared to baseline (p<0.0001). Individuals aged 2 to 12 years with balloon-only treatment demonstrated similar improvements between baseline and 6 months (p<0.0001). For participants aged 12 to 21, SNOT-22 mean scores were also significantly improved at 6 months (p<0.0001). The authors concluded that, “Balloon sinus dilation is safe and appears effective for children with CRS aged 2 years and older.”

Jia (2020) reported the 3-year follow-up results of a prospective study of 30 (65 sinuses) children (6 to 15 years of age) with 3 to 6 months of failed medical management for CRS treated with balloon sinuplasty. Outcomes were measured using a VAS for subjective symptoms, assessment of quality of life using the SN-5 (< 12 years of age) or SNOT-22 (≥ 12 years of age), and CT findings graded using Lund-Mackay scoring system. If the SN-5 was used at baseline, it was used again at follow-up for consistency of measurement. Other data collected included reports on the use of nasal medications and irrigation, revision surgeries, assessment of adverse events, and a short survey assessing degree of satisfaction with the procedure. The VAS and SN-5 or SNOT-22 scores were all reported to be significantly lower (p<0.001) at 3-year follow-up. The authors reported that post-procedure Lund-Mackay scores were significantly lower (p=0.028) compared to baseline. Participants with a significant improvement in symptoms at the time of 3-year follow-up were not reexamined by CT. However, criteria for that determination were not provided. The most common post-procedural complication was nasal cavity adhesion. Three cases were identified at 15 to 30 days after surgery and 2 cases were identified at 3-years post-procedure. One participant had several complications that led to a revision surgery by FESS in the second year after the balloon procedure and was excluded from further follow-up. The authors also reported that most participants did not require post-procedure nasal medication for symptom management and that 29 of 30 participants were satisfied with the procedure. Some limitations of this study include a small sample size, non-randomized design, and lack of comparison group.

Conclusion

Overall, the number of studies addressing the use of sinus ostial dilation continues to grow. While the quality of the data remains low, there is growing consensus in the otolaryngological practice community that the use of balloon sinus ostial dilation provides significant benefits over FESS in terms of postoperative pain, blood loss and loss of work, while delivering similar health outcome benefits. While questions of long-term outcomes remain, the use of this procedure is reasonably safe and effective when used in appropriately selected populations. Benefits from use of this procedure for the treatment of individuals with polyposis, headaches, and sleep apnea are unclear.

Acute rhinosinusitis (ARS): Up to 4 weeks of discolored nasal drainage accompanied by nasal obstruction, facial pain, pressure, or fullness. Nasal obstruction may be reported by the individual as nasal obstruction, congestion, blockage, or stuffiness, or may be diagnosed by physical examination. Facial pain, pressure, or fullness may involve the anterior face, periorbital region, or manifest with headache that is localized or diffuse.

Chronic rhinosinusitis (CRS): 12 weeks or longer of two or more of the following symptoms or signs:

• Thick and/or discolored drainage
• Nasal obstruction (congestion)
• Facial pain, pressure, or fullness
• Decreased sense of smell and inflammation as documented by one or more of the following findings:
  • abnormal mucus or edema in the middle meatus
  • radiologic imaging showing inflammation of the paranasal sinuses

Chronic Sinusitis Survey (CSS): a 6-item patient-reported outcome measure designed to assess health-related quality of life in individuals with chronic rhinosinusitis over an 8-week recall period. The instrument consists of two subscales: a symptom subscale (assessing sinus headache, facial pain/pressure, nasal drainage/postnasal drip, and nasal congestion/difficulty breathing through the nose) and a medication subscale (evaluating antibiotic use, prescribed nasal sprays, and sinus medications in pill form). The CSS has demonstrated good validity and reliability in chronic rhinosinusitis populations. The original validation study by Gliklich and Metson showed excellent test-retest reliability (0.86, p<0.0001) based on symptom duration, which was superior to severity-based scoring (0.57, p<0.0001). No specific minimal clinically important difference (MCID) has been established for the CSS in the published literature, limiting its utility for interpreting treatment response thresholds.

Complicated rhinosinusitis: Extra paranasal sinus extension, defined as extensions of disease beyond the confines of the sinuses, for example, orbital or intracranial spread.

Lund-Mackay score: A CT-based radiologic scoring system that assesses the severity of chronic rhinosinusitis by evaluating mucosal opacification in each paranasal sinus and the ostiomeatal complex. Each sinus (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) is scored bilaterally as 0 (no opacification), 1 (partial opacification), or 2 (complete opacification), with the ostiomeatal complex scored as 0 (patent) or 2 (obstructed), yielding a total score range of 0 to 24, where higher scores indicate more severe disease. The Lund-Mackay score represents the most widely established method of sinus CT scoring in clinical trials and is considered the standard for communicating radiologic extent of chronic rhinosinusitis in research. The total score demonstrates high correlation between expert rhinologists and scores derived from radiology reports (Spearman rank correlation 0.75-0.88, p<0.001), though correlation for individual sinuses is more variable. A notable limitation is the system's inability to subgrade disease within the partial opacification category (score of 1), which can represent anywhere from >0% to <100% involvement, potentially missing substantial improvements that remain within this range. The minimally important clinical difference (MCID) for the Lund-Mackay score has been estimated at 4 to 5 points.

Pediatric Chronic Rhinosinusitis: Inflammation of the nose and paranasal sinuses lasting greater than or equal to 12 weeks characterized by two of the following symptoms:

• Nasal obstruction/congestion
• Nasal discharge (anterior/posterior nasal drip)
• Chronic cough
• Facial pain/pressure and 1 objective sign of sinonasal inflammation:
  • Nasal endoscopy findings (for example, mucosal edema, purulent drainage, nasal polyps)
  • Imaging abnormalities on sinus CT consistent with mucosal disease.

Recurrent acute rhinosinusitis (RARS): Four or more episodes per year of acute bacterial rhinosinusitis (ABRS) without signs or symptoms of rhinosinusitis between episodes.

Rhinosinusitis Disability Index (RSDI): a 30-item disease-specific quality of life questionnaire that evaluates the impact of chronic rhinosinusitis on individuals' physical (0-44), functional (0-36), and emotional (0-40) domains, with total scores ranging from 0-120. Higher scores indicate worse quality of life and greater disease impact on daily function. The RSDI has demonstrated good validity and reliability across multiple studies. Validation studies have shown strong internal consistency with Cronbach's alpha of 0.936, and good content validity with 0% floor and ceiling effects for total scores. The instrument has been successfully translated and validated for use in different populations, demonstrating robust psychometric properties including strong item-own correlations (0.54-0.74 across domains) that exceed item-other domain correlations, supporting its construct validity. The minimal clinically important difference (MCID) for the RSDI is 10.35, as reported in the 2025 American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guideline on Surgical Management of Chronic Rhinosinusitis.

SN-5 (Sinus and Nasal Quality of Life Survey): a validated, disease-specific quality-of-life questionnaire for children aged 2-12 years with persistent sinonasal symptoms. The instrument consists of 5 symptom-cluster items covering sinus infection, nasal obstruction, allergy symptoms, emotional distress, and activity limitations, each rated on a 7-point frequency scale from "none of the time" to "all of the time," yielding a total score ranging from 0 to 7 (higher scores indicate worse quality of life). The SN-5 demonstrates robust psychometric properties including good test-retest reliability (R = 0.70) for the overall score and individual items (R ≥ 0.58), with adequate correlation with external constructs (R ≥ 0.36). The instrument also demonstrated good responsiveness to longitudinal change with an effect size of 0.74 and mean change score of 0.88 after routine clinical care. A specific minimal clinically important difference for the SN-5 has not been established in the published literature.

SNOT scores: The (sinonasal outcome test) SNOT-20 score is a validated, disease-specific quality-of-life measure for rhinosinusitis containing 20 items assessing nasal, sinus, and general symptoms, with scores ranging from 0-5 per item. The SNOT-22 is a modification of the SNOT-20 that adds two items (nasal blockage and sense of smell/taste) to improve comprehensiveness. Both instruments demonstrate excellent psychometric properties. The SNOT-20 shows Cronbach's alpha of 0.9 and test-retest reliability of r = 0.9, successfully discriminating between disease severity levels and detecting clinical change. The SNOT-22 demonstrates similarly robust properties with Cronbach's alpha of 0.91 and test-retest reliability of 0.93, effectively discriminating between individuals with chronic rhinosinusitis and healthy controls (p<0.0001). Factor analyses have identified 4-5 distinct domains including nasal, sleep, ear/facial, and emotional symptoms. The SNOT-22 has an established minimal clinically important difference (MCID) of 8.9 points for surgical patients, representing the smallest change detectable by patients. For medically managed individuals, the MCID is approximately 12 points, with distribution-based methods also supporting an MCID of 8.0 points. The SNOT-20 itself lacks widely established MCID values in the literature, which contributed to the development and adoption of the SNOT-22 as the preferred instrument in contemporary rhinology practice.

Synechiae formation: Development of abnormal adhesions or scar tissue between adjacent mucosal surfaces within the sinonasal cavity, often occurring after surgery or inflammation, which may result in obstruction of airflow or impaired sinus drainage.

Peer Reviewed Publications:

1. Albritton FD 4th, Casiano RR, Sillers MJ. Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation. Am J Rhinol Allergy. 2012; 26(3):243-248.
2. Alt JA, DeConde AS, Mace JC, et al. Quality of life in patients with chronic rhinosinusitis and sleep dysfunction undergoing endoscopic sinus surgery: a pilot investigation of comorbid obstructive sleep apnea. JAMA Otolaryngol Head Neck Surg. 2015; 141(10):873-881.
3. Bikhazi N, Light J, Truitt T, et al. REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. 2014; 28(4):323-329.
4. Bolger WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg. 2007; 137(1):10-20.
5. Brietzke SE, Shin JJ, Choi S, et al. Clinical consensus statement: pediatric chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2014; 151(4):542-553.
6. Brodner D, Nachlas N, Mock P, et al. Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool. Int Forum Allergy Rhinol. 2013; 3(8):652-658.
7. Chaaban MR, Rana N, Baillargeon J, et al. Outcomes and complications of balloon and conventional functional endoscopic sinus surgery. Am J Rhinol Allergy. 2018; 32(5):388-396.
8. Chandra RK, Kern RC, Cutler JL, et al. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016; 126(1):44-50.
9. Christmas DA, Mirante JP, Yanagisawa E. Endoscopic view of balloon catheter dilation of sinus ostia (balloon sinuplasty). Ear Nose Throat J. 2006; 85(11):698, 700.
10. Cutler J, Bikhazi N, Light J, et al. REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013; 27(5):416-422.
11. Friedman M, Schalch P, Lin HC, et al. Functional endoscopic dilatation of the sinuses: patient satisfaction, postoperative pain, and cost. Am J Rhinol. 2008; 22(2):204-209.
12. Gould J, Alexander I, Tomkin E, Brodner D. In-office, multisinus balloon dilation: 1-year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. 2014; 28(2):156-163.
13. Hathorn IF, Pace-Asciak P, Habib AR, et al. Randomized controlled trial: hybrid technique using balloon dilation of the frontal sinus drainage pathway. Int Forum Allergy Rhinol. 2015; 5(2):167-173.
14. Heimgartner S, Eckardt J, Simmen D, et al. Limitations of balloon sinuplasty in frontal sinus surgery. Eur Arch Otorhinolaryngol. 2011; 268(10):1463-1467.
15. Hessler JL, Piccirillo JF, Fang D, et al. Clinical outcomes of chronic rhinosinusitis in response to medical therapy: results of a prospective study. Am J Rhinol. 2007; 21(1):10-18.
16. Higgins TS Jr, Öcal B, Adams R, et al. In-office balloon sinus ostial dilation with concurrent antiplatelet and anticoagulant therapy for chronic rhinosinusitis without nasal polyps. Ann Otol Rhinol Laryngol. 2020; 129(3):280-286.
17. Hopkins C, Gillett S, Slack R, et al. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009; 34(5):447-54.
18. Hopkins C, Noon E, Bray D, Roberts D. Balloon sinuplasty: our first year. J Laryngol Otol. 2011; 125(1):43-52.
19. Jia L, Cao C, Jing B, et al. 3-year follow-up after balloon sinuplasty in children with chronic rhinosinusitis. Int J Pediatr Otorhinolaryngol. 2020; 136:110084.
20. Karanfilov B, Silvers S, Pasha R, et al. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013; 3(5):404-411.
21. Kay DJ, Rosenfeld RM. Quality of life for children with persistent sinonasal symptoms. Otolaryngol Head Neck Surg. 2003; 128(1):17-26.
22. Khan AH, Reaney M, Guillemin I, et al. Development of Sinonasal Outcome Test (SNOT-22) domains in chronic rhinosinusitis with nasal polyps. Laryngoscope. 2022; 132(5):933-941.
23. Koskinen A, Myller J, Mattila P, et al. Long-term follow-up after ESS and balloon sinuplasty: comparison of symptom reduction and patient satisfaction. Acta Otolaryngol. 2016; 136(5):532-536.
24. Kuhn FA, Church CA, Goldberg AN, et al. Balloon catheter sinusotomy: one-year follow-up--outcomes and role in functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2008; 139(3 Suppl 3):S27-37.
25. Kutluhan A, Çetin H, Kale H, et al. Comparison of natural ostiodilatation and endoscopic sinus surgery in the same patient with chronic sinusitis. Braz J Otorhinolaryngol. 2020; 86(1):56‐62.
26. Lefevre F, Rosenberg AB. Balloon dilatation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. 2012; 121(10):700.
27. Levine AB, Truitt TT, Schwartz M, Atkins J. In-office stand-alone balloon dilation of maxillary sinus ostia and ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: a prospective, multi-institutional study with 1-year follow-up. Ann Otol Rhinol Laryngol. 2013; 122(11):665-671.
28. Levine HL, Sertich AP 2nd, Hoisington DR, et al. PatiENT Registry Study Group. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol. 2008; 117(4):263-270.
29. Liang X, Lan H, Liang X, et al. Efficacy and safety of sinus balloon catheter dilation versus functional endoscopic sinus surgery in the treatment of chronic sinusitis: a meta-analysis. Medicine (Baltimore). 2025; 104(24):e42841.
30. Marzetti A, Tedaldi M, Passali FM. The role of balloon sinuplasty in the treatment of sinus headache. Otolaryngol Pol. 2014; 68(1):15-19.
31. Payne SC, Stolovitzky P, Mehendale N, et al. Medical therapy versus sinus surgery by using balloon sinus dilation technology: a prospective multicenter study. Am J Rhinol Allergy. 2016; 30(4):279-286.
32. Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg. 2002; 126(1):41-47.
33. Plaza G, Eisenberg G, Montojo J, et al. Balloon dilatation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. 2011; 120(8):511-518.
34. Ramadan HH, Bueller H, Hester ST, Terrell AM. Sinus balloon catheter dilation after adenoidectomy failure for children with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2012; 138(7):635-637.
35. Ramadan HH, McLaughlin K, Josephson G, et al. Balloon catheter sinuplasty in young children. Am J Rhinol Allergy. 2010; 24(1):e54-56.
36. Rudmik L, Hopkins C, Peters A, et al. Patient-reported outcome measures for adult chronic rhinosinusitis: a systematic review and quality assessment. J Allergy Clin Immunol. 2015; 136(6):1532-1540.e2.
37. Shin JJ, Wilson M, McKenna M, et al. (2025), Clinical practice guideline: surgical management of chronic rhinosinusitis. Otolaryngol Head Neck Surg, 172(S1-S47): S1-S47.
38. Sikand A, Silvers SL, Pasha R, et al. ORIOS 2 Study Investigators. Office-based balloon sinus dilation: 1-year follow-up of a prospective, multicenter study. Ann Otol Rhinol Laryngol. 2015; 124(8):630-637.
39. Soler ZM, Rosenbloom JS, Skarada D, et al. Prospective, multicenter evaluation of balloon sinus dilation for treatment of pediatric chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017; 7(3):221-229.
40. Stankiewicz J, Tami T, Truitt T, et al. Impact of chronic rhinosinusitis on work productivity through one-year follow-up after balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol. 2011; 1(1):38-45.
41. Stankiewicz J, Tami T, Truitt T, et al. Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. Am J Rhinol Allergy. 2009; 23(3):321-327.
42. Stankiewicz J, Truitt T, Atkins J Jr. One-year results: transantral balloon dilation of the ethmoid infundibulum. Ear Nose Throat J. 2010; 89(2):72-77.
43. Stankiewicz J, Truitt T, Atkins J, et al. Two-year results: transantral balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol. 2012; 2(3):199-206.
44. Stolovitzky JP, Mehendale N, Matheny KE, et al. Medical therapy versus balloon sinus dilation in adults with chronic rhinosinusitis (MERLOT): 12-month follow-up. Am J Rhinol Allergy. 2018; 32(4):294-302.
45. Tomazic PV, Stammberger H, Braun H, et al. Feasibility of balloon sinuplasty in patients with chronic rhinosinusitis: the Graz experience. Rhinology. 2013; 51(2):120-127.
46. Weiss RL, Church CA, Kuhn FA, et al. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg. 2008; 139(3 Suppl 3):S38-S46.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Ahmed J, Pal S, Hopkins C, Jayaraj S. Functional endoscopic balloon dilation of sinus ostia for chronic rhinosinusitis. Cochrane Database Syst Rev. 2011;(7):CD008515.
2. American Academy of Otolaryngology-Head and Neck Surgery. Surgical Clinical Practice Guideline: Management of Chronic Rhinosinusitis. May 27, 2025. Available at: https://www.entnet.org/quality-practice/quality-products/clinical-practice-guidelines/cpg-surgical-management-of-chronic-rhinosinusitis/. Accessed on April 27, 2026.
3. American Academy of Otolaryngology - Head and Neck Surgery. May 13, 2025. Debridement. Available at: https://www.entnet.org/resource/position-statement-debridement-of-the-sinus-cavity-after-ess/. Accessed on April 27, 2026.
4. American Academy of Otolaryngology - Head and Neck Surgery. Dilation of sinuses, any method (for example balloon, etc.). April 13, 2021. Available at: https://www.entnet.org/resource/position-statement-dilation-of-sinuses-any-method-e-g-balloon-etc. Accessed on March 20, 2026.
5. American Rhinologic Society. Ostial balloon dilation position statement. January 28, 2023. Available at: . https://www.american-rhinologic.org/index.php?option=com_content&view=article&id=494:ostial-balloon-dilation-position-statement&catid=26:position-statements&Itemid=197. Accessed on April 27, 2026.
6. Peters AT, Spector S, Hsu J, et al.; Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma and Immunology, the American College of Allergy, Asthma and Immunology, and the Joint Council of Allergy, Asthma and Immunology. Diagnosis and management of rhinosinusitis: a practice parameter update. Ann Allergy Asthma Immunol. 2014; 113(4):347-85.
7. Piccirillo JF, Payne SC, Rosenfeld RM, et al. Clinical consensus statement: balloon dilation of the sinuses. Otolaryngol Head Neck Surg. 2018; 158(2):203-214.
8. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015; 152(2 Suppl):S1-S39.
9. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Next Generation Balloon Dilation System Summary. No. K201115. Silver Spring, MD: FDA. August 27, 2020. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201115.pdf. Accessed on April 27, 2026.

1. National Library of Medicine. Medical Encyclopedia. Sinusitis. Review date 5/2/2024. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000647.htm. Accessed on March 20, 2026.

Acute rhinosinusitis (ARS)
Balloon dilatation
Balloon Sinuplasty
Entellus FinESS
Chronic rhinosinusitis (CRS)
Complicated rhinosinusitis
ENTrigue^® Sinus Dilation System
FinESS
Next Generation Balloon Dilation System
NuVEnt EM Sinus Dilation System
Pediatric Chronic Rhinosinusitis (PCRS)
Recurrent acute rhinosinusitis (RARS)
Relieva Seeker Balloon Sinuplasty System^®
Relieva Sinus Balloon Catheter
Relieva Sinus Exchange Catheter
Relieva Sinus Guide Catheter
Relieva Sinus Guidewire
Relieva Sinus Inflation Device
Relieva Sinus Lavage Catheter
Relieva Spin Sinus Dilation System^®
Sinusitis
Synechiae formation
XprESS Multi-Sinus Dilation Tool

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