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Clinical Results

Entellus Medical has sponsored seven studies with more than 450 patients to explore the safety and efficacy of balloon sinus dilation. Take a look at the highlights.

REMODEL Study

Study Overview

REMODEL is the first controlled trial with sufficient statistical power to compare standalone Balloon Sinus Dilation to the standard of care, Functional Endoscopic Sinus Surgery (FESS) for the treatment of medically refractory CRS.1

Overall Success

Both techniques produced comparable success rates. 89/92 patients treated (97%) completed 12-Month follow-up

Balloon Dilation Success Rate2

 

FESS Success Rate3

 

Primary Outcomes

  The mean number of debridements per patient were significantly less* in patients who had balloon dilation

Recovery and Short term Outcomes

Benefits of balloon dilation compared to FESS

  Patients discharged with nasal bleeding

  Recovery time

  Duration of prescription pain medications

  Short-term mean change in SNOT-20

1-Year Outcomes

Balloon dilation has comparable efficacy as FESS

  Mean change in number of rhinosinusitis episodes per patient

  Ostial patency

  Mean percent reduction of activity impairment due to CRS

  Mean percent reduction in overall work impairment due to CRS

  Complications

  Revision surgery rate

Standalone balloon dilation performed in the physicians office is proven to be safe, effective, and a beneficial alternative to FESS in patients with uncomplicated CRS

View full study results & data