Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps

Exclusion Criteria

• •Candidates were excluded if they met ANY of the following criteria:
• •1. Patient had bilateral total ethmoidectomy less than 90 days previously.
• •2. Patient had Propel implanted postoperatively less than 90 days previously.
• •3. Patient has presence of adhesions/synechiae Grades 3 or 4.
• •4. Patient has presence of severe scarring or adhesions within the ethmoid cavity itself.
• •5. Patient has presence of Grade 4 polyposis.
• •6. Patient has known history of immune deficiency (e.g., IGG\] subclass deficiency or IGA deficiency, HIV).
• •7. Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.).
• •8. Patient has oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD), asthma or other condition.
• •9. Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate (MF).
• •10. Patient has known history of resistance or poor response to oral steroids.
• •11. Patient has presence of physical obstruction that would preclude access to either ethmoid sinus for device delivery (e.g., severe septal deviation, septal spur, very small middle meatus, total obstruction of the nasal passage with severe scarring, polyposis).
• •12. Patient has clinical evidence of acute bacterial sinusitis (e.g., acute increase in purulent discharge, fever, facial pain etc.).
• •13. Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on prior CT scan, necrotic sinus tissue, etc.).
• •14. Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 6 month follow-up period.
• •15. Patient is currently participating in or recently participated in another clinical trial (within the last 30 days).
• •16. Patient has history of insulin dependent diabetes mellitus.
• •17. Patient has previously undergone ESS and experienced a CSF leak or has residual compromised vision as a result of a complication in a prior ESS procedure.
• •18. Patient has completely resected middle turbinate.
• •19. Patient has known dehiscence of the lamina papyracea.
• •20. Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes simplex, chickenpox, or measles).
• •21. Patient has history or diagnosis of glaucoma or ocular hypertension (baseline or a known prior ocular exam indicating IOP \>21 mm Hg)
• •22. Patient has closed angle (with or without the presence of peripheral anterior synechiae on gonioscopy)
• •23. Patient has presence in either eye of: (i) posterior subcapsular cataract, (ii) nuclear sclerosis of Grade +3 or higher; or (iii) cortical cataract of Grade +3 or higher.