2018 Section 5 - Rhinology and Allergic Disorders

RESOLVE 6-month outcomes

NOSE Score vs. Time (days)

0

30

60

90

120

150

180

0

-5

-10

-15

-20

Change from baseline

-25

*

-30

-35

Treatment

Control

FIGURE 5. Change from baseline in NOSE scores during 6 months following sinus implant placement (treatment) or sham procedure (control). * p < 0.05 vs control. NOSE = Nasal Obstruction Symptom Evaluation.

0

30

60

90

120

150

180

0

-0.2

-0.4

-0.6

-0.8

-1

-1.2

Change from baseline

-1.4

-1.6

-1.8

Treatment

Control

FIGURE 6. Change from baseline in nasal obstruction/congestion score during 6 months following sinus implant placement (treatment) or sham procedure (control). Means obtained from analysis of covariance with baseline values as covariate and the site and treatment group as fixed effects.

new safety questions raised during longer-term follow-up, the study demonstrates the safety of the steroid-eluting si- nus implant. The efficacy of the steroid-eluting implant was demon- strated using a combination of objective and subjective

measures. We observed significant reductions in bilateral polyp grade and percent ethmoid sinus obstruction as judged endoscopically by clinical investigators and cor- roborated by an independent panel of 3 surgeons. These objective endoscopic findings appear to have correlated

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