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Patient Selection

Clinical data show balloon dilation is an effective treatment option for wide range of sinusitis sufferers

Published clinical outcomes, inclusive of a wide range of patients, sinuses treated, sinusitis present, and other patient conditions, define the range of patients who can be effectively treated with balloon sinus dilation, including those with:

  • Chronic rhinosinusitis (CRS)
  • Recurrent acute rhinosinusitis
  • Isolated or multi-sinus disease
  • Mild to moderate septal deviation
  • Frontal, sphenoid, maxillary or maxillary and anterior ethmoid disease
  • Accessory ostia

Even patients with nasal polypsis show statistically significant symptom improvement from balloon dilation when the procedure is performed adjunctively with FESS.

Explore the key data below:

Multi-Sinus

XprESS Multi-Sinus Study: Mean 1-Year Change in SNOT-20 Score by Sinuses Dilated

Sinuses Treated n 1-Year Change p- value*
Maxillary 21 -1.35 <0.0001
Maxillary+Sphenoid 5 -1.29 0.017
Maxillary+Frontal 27 -1.74 <0.0001
Maxillary+Frontal+Sphenoid 22 -1.64 <0.0001

*Comparison of mean change from baseline to 1-yr follow-up; p-value from paired t-test.

Clinically meaningful & statistically significant improvement obtained for all sinus dilation subgroups.

Accessory Ostium

REMODEL 6-month Subgroup Analyses (SNOT-20)

Subgroup Balloon Dilation Control (FESS) p- value*
n Mean Change n Mean Change
Accessory Ostium
Yes 17 -1.8 9 -1.9 NS
No 31 -1.6 32 -1.5 NS

NS=Not significant
*Comparison of difference between study arms; p-value from two-sample t-test.

Patients with or without accessory ostia experienced similar symptom improvement, whether treated with balloon dilation or functional endoscopic sinus surgery.

CRS and Recurrent Acute Rhinosinusitis

REMODEL 6-month Subgroup Analyses (SNOT-20)

Subgroup Balloon Dilation Control (FESS) p- value*
n Mean Change n Mean Change
Rhinosinusitis Diagnosis
CRS 32 -1.7 28 -1.6 NS
Recurrent acute 16 -1.6 13 -1.6 NS

NS=Not significant
*Comparison of difference between study arms; p-value from two-sample t-test.

Both CRS and recurrent acute patients experienced similar symptom improvement in both arms of the REMODEL randomized controlled trial comparing balloon dilation and functional endoscopic sinus surgery (FESS).


RELIEF Study In-Office Results (SNOT-20)

Symptom Improvement (Average SNOT-20) Through 1-Year

Statistically significant (p < 0.001) & clinically meaningful (Δ ≥ 0.8) improvement in both chronic and recurrent acute sinusitis patients

Septal Deviation

Symptom Improvement for Septal Deviation Patients (SNOT-20)

The above data from a poster presented at 2013 ARS Annual Meeting shows both mild and moderate septal deviation patients experienced clinically meaningful (Δ ≥ 0.8) & statistically significant (p < 0.0001) symptom improvement following treatment with balloon sinus dilation.


REMODEL 6-month Subgroup Analyses (SNOT-20)

Subgroup Balloon Dilation Control (FESS) p- value*
n Mean Change n Mean Change
Septal Deviation
Yes 28 -1.7 24 -1.6 NS
No 20 -1.7 17 -1.7 NS

NS=Not significant
*Comparison of difference between study arms; p-value from two-sample t-test.


XprESS Multi-Sinus Study Subgroup Analyses (SNOT-20)

Subgroup n Baseline 1-Year Change p- value*
Septal Deviation
Yes 43 2.15 -1.65 <0.0001
No 32 2.42 -1.46 <0.0001

*Comparison of mean change from baseline to 1-yr follow-up; p-value from paired t-test.

REMODEL shows balloon dilation and FESS deliver comparable symptom improvement to patients with and without septal deviation; XprESS Multi-Sinus study affirms balloon dilation delivers clinically meaningful & statistically significant improvement for patients with and without septal deviation.

Nasal Polyposis

XprESS Registry Study (SNOT-20)

1 Matched-pair (t-test) analysis, p-value < 0.05; Publication: Brodner, IFAR 2013

  • 44 patients; 30% with nasal polyposis & hybrid treatment
  • Statistically significant1 and clinically meaningful (Δ ≥ 0.8) improvement at each follow-up
  • Symptom improvement was similar for patients with or without nasal polyposis prior to surgery.


Patients with the Following Conditions May Not be Best Suited for Standalone Balloon Dilation Treatment

  • Eosiniphilic disease
  • Severe polyposis or fungal sinusitis
  • Severe septal deviation
  • Cystic fibrosis
  • Samter’s triad
  • Facial trauma

Learn More about Patient Selection

References

XprESS Multi-Sinus

In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial.
Gould J; Alexander I; Tomkin E; Brodner D. American Journal of Rhinology & Allergy doi: 10.2500/ajra.2014.28.4043.

REMODEL

Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up
N. Bikhazi; J. Light; M. Schwartz; T. Truitt; J. Cutler; REMODEL Study Investigators. Am J Rhinol Allergy doi.org/10.2500/ajra.2014.28.4064.

Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial.
Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M. Am J Rhinol Allergy doi.org/10.2500/ajra.2013.27.3970.

RELIEF

In-office stand-alone balloon dilation of maxillary sinus ostia ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: A prospective, multi-institutional study with 1-year follow-up.
Levine S, Truitt T, Schwartz M, Atkins J. Ann Otol Rhinol Laryngol 122(11):665-671, 2013. 

Septal Deviation

Does Office-Based Balloon Dilation Effectively Treat Chronic Rhinosinusitis Patients with Mild to Moderate Septal Deviation?
Brodner, D. ENT Journal. Vendome Healthcare Media, 19 Dec 2013. View paper.

XprESS Registry

Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunctional, multisinus balloon dilation tool.
Brodner D, Nachlas N, Mock P, etal. Intl Forum Allergy & Rhinol. 2013 Feb 19. doi: 10.1002/alr.21156.