Safety and Performance of ENTACT Septal Staple System for Septoplasty

Exclusion Criteria

• •1. Prolonged tissue approximation beyond that needed for normal tissue closure is necessary or desired;
• •2. Traditional suturing techniques are necessary;
• •3. Radiopacity is necessary or desired since ENTACT septal staples are radiotransparent;
• •4. Known to be allergic to foreign body of materials of investigational product;
• •5. Concomitant procedures other than turbinectomy, turbinate reduction, and/or sinus surgery;
• •6. Pregnancy at time of procedure;
• •7. Presence of infection at the site;
• •8. Severe drug and alcohol abusers;
• •9. Autoimmune disease deemed clinically significant by Principal Investigator (PI).