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

A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of TurbAlign™ to Achieve Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery (FESS) (GAIA)

A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery

To evaluate the safety and effectiveness of the Spirair implant as a primary treatment to achieve medialization of the middle turbinate after functional endoscopic sinus surgery.

Inclusion Criteria:

• ≥18 to ≤ 75 years of age at time of consent
• Subject scheduled to undergo bilateral endoscopic sinus surgery
• Willing and able to provide informed consent and comply with the study protocol

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