Overview
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
Description
To evaluate the safety and effectiveness of the Spirair Implant as a primary treatment for correction of cartilaginous nasal septal deviation.
Eligibility
Inclusion Criteria:
- ≥21 to ≤ 70 years of age at time of consent
- Seeking treatment for nasal airway obstruction (NAO) symptoms due primarily to cartilaginous nasal septal deviation
- Willing to undergo a nasal implant procedure
- NOSE score ≥30 at Baseline Visit
- Non-calcified, mobile cartilaginous nasal septal deviation
Exclusion Criteria:
- Target nasal septal deviation that is calcified or non-mobile
- Previous septoplasty or rhinoplasty
- Having a concurrent ENT procedure, other than turbinate reduction
- Saddle nose deformity
- Congenital nasal defect
- Documented evidence that middle meatus is not visualized on endoscopic exam due to severe septal deviation
- Turbinate reduction within the past six (6) months
- Permanent implant or dilator in the nose