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