Device Debut: Sinuva Marks Next Step In Intersect ENT's Evolution Into A Combo Products Company
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.
You may also be interested in...
The Israeli portfolio company of The Trendlines Group announced that US FDA 510(k)-cleared its composite removable sinus stent system based on results of a 30-patient trial.
Original new drugs and biologics recently approved by US FDA.
Encouraging pilot trial results on a drug-eluting implant for sinusitis made by Intersect ENT. First-in-man procedure with myocardial anchoring system for heart failure from BioVentrix. Final analysis of registry data confirms the efficacy of Hologic’s MammoSite breast brachytherapy system.