Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study

Inclusion criteria

• The subject has Nasal Obstruction Symptom Evaluation (NOSE) Score ≥55.
• The subject has dynamic lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver22.
• The subject is ≥18 years of age.
• The subject is willing and able to provide informed consent and comply with the study protocol.
• The subject is seeking treatment for nasal airway obstruction due to Nasal Valve Collapse (NVC) and is willing to undergo nasal Implant procedure alone or with septoplasty and/or a turbinate reduction procedure in an operating room setting.
• The subject has appropriate nasal and facial anatomy to receive Latera Implant.
• The subject agrees to follow-up examinations through twelve (12) months post operatively.
• The subject has failed a trial of appropriate maximal medical management [e.g., nasal steroids (at least 4 weeks); antihistamines; oral decongestants; nasal strips, stents, or cones]. Failure of maximal medical management may be from lack of effectiveness or inability of subject to tolerate.

Exclusion criteria

• The subject is having a concurrent Functional Endoscopic Sinus Surgery (FESS) or sinuplasty.
• The subject has had rhinoplasty within the past twelve (12) months.
• The subject is planning to have other concurrent rhinoplasty procedure.
• The subject is planning to have other rhinoplasty procedures or will use external dilators within twelve (12) months after the index procedure.
• The subject has had septoplasty and/or inferior turbinate reduction within the past six (6) months.
• The subject has, in the view of the clinician, inappropriate fixation on their nasal airway.
• The subject plans to have any surgical or non-surgical treatment of their nasal valve, other than the index procedure, within twelve (12) months of the study.
• The subject has a permanent Implant or dilator in the nasal area.
• The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area.
• The subject currently has active nasal vestibulitis.
• The subject has a history of nasal vasculitis.
• The subject is a chronic systemic steroid or recreational intra-nasal drug user.
• The subject has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
• The subject has polyps or pathology other than septal deviation and/or turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction.
• The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure.
• The subject has a known or suspected allergy to poly lactic acid (PLA) or other absorbable materials.
• The subject has a significant systemic disease such as poorly controlled diabetes which, in the investigator's opinion, could pre-dispose the subject to poor wound healing.
• The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).
• The subject is not a candidate for procedures conducted under general anesthesia, managed anesthesia care (MAC) or conscious sedation.
• If female, subject is known or suspected to be pregnant or is lactating.