SPL Set ID: e33c1b23-cdc6-4f64-94ba-24b0b42c09bf
1 drug(s) with this SPL Set ID
The SINUVA Sinus Implant is a self-expanding, bioabsorbable, drug eluting implant provided with a crimper and a single-use delivery system. SINUVA Sinus Implant is comprised of poly(L-lactide-co-glycolide) and poly(L-lactide-co-⃞-caprolactone) coated with mometasone furoate embedded in a bioabsorbable polymer matrix containing poly(DL-lactide-co-glycolide) and polyethylene glycol (inactive ingredients) which provides for gradual release of the drug. The SINUVA Sinus Implant is packaged in a tray, which is then sealed in a foil pouch and placed in the product carton. The SINUVA Sinus Implant is provided sterile. Mometasone furoate, the active component of the SINUVA Sinus Implant, is a corticosteroid with the chemical name 9,21-dichloro-11(⃞),17-dihydroxy-16(⃞)-methylpregna-1,4-diene-3,20- dione 17 (2-furoate). Mometasone furoate is a white powder with an empirical formula of C 27 H 30 Cl 2 O 6 , and molecular weight of 521.44 Daltons. The chemical structure of mometasone furoate is shown below: The inactive ingredients are poly-(DL-lactide-co-glycolide) and polyethylene glycol. Poly-(DL-lactide-co-glycolide) is an amorphous biodegradable polymer. Chemical Structure