The Safety and Efficacy of a Bioabsorbable Implant for Correction of Cartilaginous Septal Deviation

Abstract

Introduction: Nasal septal deviation (NSD) is a leading cause of nasal airway obstruction, a condition that adversely affects quality of life. Septoplasty, typically performed with inferior turbinate reduction (ITR), is a common treatment to correct NSD. Methods: We conducted a prospective feasibility study of a novel, minimally-invasive implant (SeptAlign TM ) to correct cartilaginous NSD as an alternative to traditional open septoplasty. The implant was inserted either in the operating room or at the medical office. ITR was performed in conjunction with the implant procedure. Results: We present 12 month results for 14 participants with mobile cartilaginous NSD. The procedure and implant were well-tolerated. At the 12th month post-procedure, the median Nasal Obstruction Symptom Evaluation (NOSE) score improved 71.8% from baseline (58-15; P = .001) and the median Sino-Nasal Outcome Test-22 (SNOT-22) score improved 60.3% from baseline score (37-8; P = .004). Most of the improvement in symptoms occurred within the first month following the procedure at which point 92.9% and 78.6% of participants were considered NOSE and SNOT-22 responders, respectively. Conclusion: These initial findings support the safety, tolerability, and early efficacy of the SeptAlign TM implant with concomitant ITR and suggest that the implant procedure can be safely performed in a medical office setting. Based on these promising initial data, larger, randomized, controlled studies should be conducted. ClinicalTrials.gov: NCT05967169; https://clinicaltrials.gov/study/NCT05967169?term=Spirair&rank=2