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Patient Tolerance

Physicians Can Achieve High Patient Comfort When Utilizing Entellus Devices

Five studies reported pain scores for office based balloon dilation procedures. Four studies utilized Entellus devices; one study was sponsored by Acclarent, Inc. and utilized Relieva Solo Pro. All five studies utilized a 0 (no pain) to 10 (severe pain) discomfort scale.

For the Entellus studies, patients overall mean procedure pain levels were low—2.8.

Clinical Study n Average Pain Score
(0=No Pain; 10=Severe Pain)
XprESS Multi-Sinus 81 2.8
XprESS Maxillary Only 21 1.8*
RELIEF (In-office FinESS) 69 3.2
BREATHE I (In-office FinESS) 19 2.7
ORIOS2 (Acclarent in-office) 198 4.5

*(A subset of patients who were administered oral sedative and narcotic pain medication prior to the procedure reported an average pain score of 1.1)

Learn More about Ensuring Patient Comfort

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. 

XprESS Maxillary Only

In-office balloon dilation: Procedure techniques and outcomes using a malleable multi-sinus dilation tool.
Gould JD. ENT Journal. Vendome Healthcare Media, 19 Dec 2012.

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. 

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.

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.