REMODEL Larger Cohort With Long-term Outcomes and Meta-Analysis of Standalone Balloon Dilation Studies.
Rakesh Chandra MD, Robert Kern MD, Jeffrey Cutler MD, Kevin Welch MD, Paul Russell MD. The Laryngoscope. Article first published online: 30 JUL 2015 DOI: 10.1002/lary.25507.
A new article published in The Laryngoscope provides the most comprehensive analysis of clinical outcomes for balloon sinus dilation reported to date, including new data from the REMODEL trial and a meta-analysis of patient level data from 6 key standalone balloon sinus dilation studies sponsored by Entellus Medical.
New REMODEL DATA
REMODEL is the first prospective, multicenter, randomized controlled trial with sufficient statistical power to compare standalone balloon sinus dilation to traditional functional endoscopic sinus surgery (FESS) for the treatment of chronic or recurrent sinusitis.
This article includes results from a larger cohort of REMODEL patients than previous publications and outcomes for follow-up results out to 24 months.
Highlights from the REMODEL larger cohort data:
- 24 month follow-up results were consistent with 6-month and 12-month outcomes; at each time point, both balloon sinus dilation and FESS delivered comparable levels of significant and clinically meaningful symptom improvement
- Larger cohort of patients affirmed benefits of balloon sinus dilation reported in earlier REMODEL publications, including faster recovery, less postoperative pain, and fewer debridements
Meta-Analysis of 6 Trials — 358 Patients
The article also compares data from 6 standalone balloon sinus dilation studies sponsored by Entellus Medical, including 358 patients (846 sinuses) with 6 months to 2 years of follow-up.
- A high 97.5% overall success rate across all six studies
- Significant, clinically meaningful, durable symptom improvement
- Quick recovery time — 1.4 days on average
- Patients experienced improvements in productivity, and decreases in activity impairment and healthcare utilization
- Outcomes consistent across a wide range of patients—both CRS and RARS patients, and patients with and without ethmoid disease
Overall, this publication demonstrates the breadth of clinical data available on balloon sinus dilation outcomes, and affirms balloon dilation’s place in the sinusitis treatment continuum.