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Safety

Balloon Sinus Dilation is Safe Whether Performed in OR or Office Setting

Study Site of Service n Complication Rate
REMODEL Office 50 0.0%
XprESS Multi-Sinus Office 81 0.0%
RELIEF Office 69 0.0%
ORIOS2* Office 203 0.0%
ORIOS* Office 37 0.0%
BREATHE Hospital, ASC & Office 71 1.4%
XprESS Registry*1,2 Hospital, ASC 175 0.0%
CLEAR*1 Hospital, ASC 109 0.0%
Total   795 0.1%

Complication = serious adverse events related to the balloon device or balloon procedure.
Note: FESS complication rates are approximately 1.0% [May & Levine 1994, Rombout 2001]
ASC = ambulatory surgical center. Hospital = outpatient department.
1Includes both standalone balloon patients and hybrid balloon patients.
2Two (1.1%) nonserious adverse events were reported following hybrid-balloon dilation and both were unrelated to the device or the procedure.
*Denotes non-Entellus balloon technology

Across eight balloon studies (795 patients) the reported complication rate is a low 0.1%. These complication rates were consistently low, whether the balloon procedure was performed in the office or an OR setting.

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.

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.

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.

BREATHE I

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.

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.

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.

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.