Meta-Analysis

• 97.5% pooled technical success rate for 6 studies (825/846 sinuses)
• Relevant studies: REMODEL, XprESS Multi-Sinus, XprESS Maxillary Pilot, RELIEF, FinESS Registry, BREATHE

Low rate of revision

• Data show a low need of revision surgery for balloon sinus dilation patients at 12 months:
  • 3.2% pooled single arm balloon dilation studies
• This data is aligned with results from the REMODEL study, which showed no statistical difference between balloon sinus dilation and functional endoscopic sinus surgery arms at 12-months:
  • 1.4% REMODEL balloon sinus dilation arm
  • 1.7% REMODEL FESS arm
• Relevant studies: REMODEL, XprESS Multi-Sinus, RELIEF, FinESS Registry, BREATHE

Comfortable office-based procedure

• Data affirms procedure can be performed comfortably in the office:
  • Low 2.6 mean pain score, on a 0 - 10 scale, where 0=0 no pain and 10=worst conceivable pain
• Relevant studies: XprESS Multi-Sinus, RELIEF, BREATHE, XprESS Maxillary Pilot

Limited post-operative bleeding, need for pain medications, and debridements

• Bleeding, post-operative pain and debridements can negatively impact patient treatment experience. Data show balloon sinus dilation patients had:
  • 13.8% (32/232) balloon patients reported nasal bleeding
  • 0.8 days mean time prescription pain medications taken
  • 0.16 mean debridements per patient
• Relevant Studies: REMODEL, XprESS Maxillary Pilot, RELIEF, BREATHE

Quick recovery

• Balloon sinus dilation patients reported a quick return to normal activities:
  • 1.4 days - mean recovery time
• Relevant studies: REMODEL, XprESS Pilot

Improved productivity; decreased activity impairment and healthcare utilization

• Clinical trials used both the Work Limitation Questionnaire and Rhinosinusitis Symptom Inventory to understand the impact of treatment on quality-of-life and productivity measures. Data highlights:
• Rhinosinusitis Symptom Inventory data show a statistically significant improvements in key lost productivity measures as well as decreases in healthcare utilization. Select highlights:
  • Mean number of days homebound due to nasal problems: 12 months before treatment: 8.3; 12 months after treatment: 2.0
  • Mean number of antibiotic courses: 12 months before treatment: 4.5; 12 months after treatment: 1.6
• Relevant studies: REMODEL, XprESS Multi-Sinus, RELIEF, FinESS Registry, BREATHE

Meta-analysis demonstrates:

1. Significant and durable benefit of balloon dilation in a large series of patients (n=358), among whom 74 were followed to 2 years
2. No significant difference in symptom improvement and revision rates between the REMODEL FESS arm (n=59) and a large standalone balloon dilation patient sample (n=314)
3. Standalone balloon sinus dilation can be performed as an in-office procedure, with faster recovery, decreased post-procedural pain, and less requirement for debridement