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Symptom Reduction

Across multiple studies, balloon sinus dilation has delivered statistically significant, clinically meaningful, and enduring relief of sinusitis symptoms

In REMODEL, the first prospective, multi-center, randomized controlled trial with sufficient statistical power to compare standalone balloon sinus dilation to traditional functional endoscopic sinus surgery (FESS), balloon dilation delivered symptom relief comparable to FESS.

Across multiple studies, symptom improvement is consistent

and stable from 6-months to 1-year to 2-year follow-up.

References

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.

BREATHE I

Two-year results: transantral balloon dilation of the ethmoid infundibulum.
Stankiewicz J, Truitt T, Atkins J, Winegar B, Cink P, Ravi J, Henderson D, Tami T. Intl Forum Allergy Rhinol. 2012 May-June; 2(3): 199-206.

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. 

ORIOS

Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation.
Albritton FD 4th, Casiano RR, Sillers MJ. Am J Rhinol Allergy. 2012 May-Jun;26(3):243-8.

ORIOS2

Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients.
Karanfilov B, Silvers S, Pasha R, Sikan A, Shikani A, Sillers MJ. Int Forum Allergy Rhinol. 2012 Nov 7; doi: 10.1002/alr.21112.

CLEAR

Long term outcome analysis of balloon catheter sinusotomy: two-year follow-up
Weiss RL, Church CA, Kuhn FA, Levine HL, Sillers MJ, Vaughan WC. Oto-Head and Neck Surg. 2008 Sep; 139(3 Suppl 3); S38-S46.

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.