S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

Exclusion Criteria

• •Patient has presence of polyposis grade 1, 1.5 or 4 on either side
• •Patient has presence of adhesions/synechiae grades 3 or 4
• •Patient has known history of immune deficiency
• •Patient has concurrent condition such as cancer or HIV requiring active chemotherapy and/or immunotherapy management for the disease
• •Patient has oral-steroid dependent condition such as COPD, asthma or other condition
• •Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate
• •Patient has presence of physical obstruction that would preclude access to either ethmoid sinus for implant delivery (e.g., severe septal deviation, septal spur, very small middle meatus, total obstruction of the nasal passage with severe scarring, polyposis)
• •Patient has clinical evidence of acute bacterial sinusitis
• •Patient has clinical evidence or suspicion of invasive fungal sinusitis
• •Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day follow-up period
• •Patient is currently participating in another clinical trial or has already participated in this clinical trial
• •Patient has history of insulin dependent diabetes mellitus
• •Patient has previously undergone ESS and experienced a cerebrospinal fluid (CSF) leak or has residual compromised vision as a result of a complication in a prior ESS procedure
• •Patient has known dehiscence of the lamina papyracea
• •Patient has evidence of active viral illness
• •Patient has known history or diagnosis of glaucoma or ocular hypertension (prior ocular exam with IOP\>21 mm Hg and pressure lowering medication given) or posterior subcapsular cataract