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Technical Success

Published data shows balloon dilation of the frontal, sphenoid and maxillary/ethmoid infundibulum can be consistently and successfully performed by physicians in the office and the OR:

Success Rate Treating Targeted Sinuses

Study Sinuses Dilation Success/Attempts Success Rate
REMODEL Maxillary/ethmoid infundibula 97/98 99%
XprESS Multi-Sinus Frontal, sphenoid, and maxillary/ethmoid infundibula 307/313 98%
RELIEF Maxillary/ethmoid infundibula 124/135 92%
XprESS Registry Frontal, sphenoid, and maxillary/ethmoid infundibula 479/497 96%
BREATHE Maxillary/ethmoid infundibula 129/132 98%
Achar * Frontal and maxillary 35/35 100%
Plaza * Frontal 22/24 92%
ORIOS2* Frontal, sphenoid, and maxillary 552/592 93%
CLEAR * Frontal, sphenoid, and maxillary 347/358 97%

* Denotes non-Entellus Balloon Technology.

Recent Office Based Studies: Two studies utilizing Entellus technology reported technical success rates of over 98%.

Office and OR Studies: Over 95% success rate (2,092 successful dilations out of 2,184 attempts) across nine studies.

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.

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.

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.  

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.

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.

First clinic experience: patient selection and outcomes for ostial dilation for chronic rhinosinusitis.
Cutler J, Truitt T, Atkins J, Winegar B, Lanier B, Schaeffer BT, Ravi J, Henderson D, Duncavage J, Stankewicz J, Tami T. Intl Forum Allergy Rhinol. 2011 Nov-Dec; 1(6): 460-465.

Achar

Endoscopic dilatation sinus surgery (FEDS) versus functional endoscopic sinus surgery (FESS) for treatment of chronic rhinosinusitis: a pilot study.
Achar P, Duvvi S, Kumar BN. Acta Otorhinolaryngol Ital. 2012; 32, 314-319. 

Plaza

Balloon dilation of the frontal recess: a randomized clinical trial.
Plaza G, Eisenberg G, Montojo J, et al. Ann Otol Rhinol Laryngol. 2011. Aug;120 (8):511-8.

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.