Device Debut: Sinuva Marks Next Step In Intersect ENT's Evolution Into A Combo Products Company
Executive Summary
US FDA approved a New Drug Application for Intersect ENT's Sinuva mometasone furoate-eluting sinus implant in December. The implant elutes the cortical steroid to treat recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery and is supported by data from 400 patients, including the results from the RESOLVE II trial that showed Sinuva dramatically reduced the proportion of patients who needed another endoscopic sinus surgery.
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