Safety and Effectiveness of a Bioabsorbable Septal Implant for Cartilaginous Nasal Septal Deviation

ABSTRACT Objective Nasal airway obstruction (NAO) can be due to deviation of the cartilaginous and bony nasal septum. Correcting the caudal cartilaginous septum can be technically challenging. This study aims to evaluate the safety and effectiveness of a bioabsorbable submucosal septal implant (SeptAlign; Spirair Inc.) for minimally invasive correction of cartilaginous nasal septal deviation (NSD). Methods This was a prospective cohort study conducted at nine otolaryngology clinics in the USA. Subjects underwent placement of the implant alone or with concurrent inferior turbinate reduction (ITR). Percentage reductions relative to baseline in the mean Nasal Obstruction Symptom Evaluation (NOSE) score were calculated at 3 and 6 months postprocedure. Results In 80 subjects (92.5% with moderate‐to‐severe NSD), NOSE scores decreased by 63.2% (from 67.5 at baseline to 26.0 at 3 months and 23.6 at 6 months; p values < 0.0001). Overall, 85.9% of subjects at 3 months and 89.9% at 6 months were considered responders. The sub‐group with concurrent turbinate reduction had 88.2% responders and the sub‐group with the implant alone had 91.4% responders at 6 months. Subjects returned to work a median of 1 day after the procedure, which was performed in‐office under local anesthesia in 46.3% of cases. Conclusion The septal implant was an effective treatment for NAO symptoms via NSD repair and was generally safe and well tolerated. It straightens cartilaginous NSD via mechanical traction without the need for resection and may be an attractive alternative to conventional septoplasty. Level of Evidence 3