Research Briefs: Data From Intersect ENT, BioVentrix and Hologic
This article was originally published in The Gray Sheet
Executive Summary
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.
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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.
Intersect Follows Leaders In ENT
Following the lead of ENT start-ups like Acclarent and Entellus Medical, Intersect ENT Inc. is introducing a line of stent like implants capable of performing the same role drug-eluting stents played in interventional cardiology. Intersect’s implants provide moderate structural support to tissue that has been cut or dilated through FESS or balloon sinuplasty. But the principal function of the implant isn’t propping open nasal passageways but rather delivering drugs. A trio of clinical studies conducted by the company has found the released steroids produced statistically significant reductions in inflammation, polyp formation, and postoperative adhesions.
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