Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis

A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).

Inclusion Criteria:

• Patient is 18 years of age or older
• Patient has a diagnosis of chronic sinusitis
• Patient has a clinical indication for and has consented to FESS
• Patient CT scan confirms CS diagnosis within 6 months of procedure
• CT sacn confirms presence of disease in ethmoid sinus(es)
• Planned FESS includes unilateral or bilateral total ethmoidectomy

Exclusion Criteria:

• Immune deficiency (IGG subclass deficiency or IGA deficiency)
• Oral-steroid dependent COPD, asthma or other condition
• Clinical evidence of acute bacterial sinusitis
• History or diagnosis of glaucoma or ocular hypertension
• Clinical evidence or suspicion of invasive fungal sinusitis
• Evidence of disease or condition expected to compromise survival or ability to complete follow-up
• Known history of allergy or intolerance to corticosteroids
• History of insulin dependent diabetes