Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum (MTI)

Inclusion Criteria:

• Subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery.
• Subject is able to provide a signed informed consent form.
• Subject will agree to comply with all study-related procedures.

• Subject is not pregnant at this time by confirmation of one of the following:

  • Subject is male
  • Subject not of child bearing age
  • Subject is surgically sterile
  • Subject is not pregnant per negative hCG test
  • Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.

Exclusion Criteria:

• Subject does not meet inclusion criteria.
• Presence of non-viable tissue at the implantation site.
• History of septal perforation.
• History of polyps.
• Presence of concha bullosa.
• Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea.
• Subject is participating in a clinical trial which could affect the healing of the middle turbinate.
• Subject has uncontrolled diabetes.

• Subject is a:

  • smoker
  • severe drug abuser
  • severe alcohol abuser
• Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.