Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery

Exclusion Criteria

• •History of removal of one or both middle turbinates
• •Presence of significant concha bullosa, which requires surgical excision
• •Presence of non-viable tissue at the implantation site
• •Active infection at the implantation site
• •Chronic nasal decongestant use (i.e. Afrin, etc)
• •Recreational intra-nasal drug use within 12 months of enrollment
• •Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
• •Hypersensitivity to any investigational device materials including known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials