Funding sources for the study: Intersect ENT provided funding for the investigation as well as administrative and logistical support in coordinating the study across the study sites. Potential conflict of interest: A.H.M., A.S.M., P.H.H., and B.J.L. are consultants for Intersect ENT. T.L.S. is a consultant for Intersect ENT and Entrigue, Inc., and has received grant funding from the NIH. N.B. is a consultant for Intersect ENT and Entellus, Inc. J.W.S. is Vice President, Clinical and Regulatory Affairs for Intersect ENT.
Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent†
Article first published online: 8 FEB 2011
Copyright © 2011 American Rhinologic Society-American Academy of Otolaryngic Allergy, LLC
International Forum of Allergy & Rhinology
Volume 1, Issue 1, pages 23–32, January/February 2011
How to Cite
Murr, A. H., Smith, T. L., Hwang, P. H., Bhattacharyya, N., Lanier, B. J., Stambaugh, J. W. and Mugglin, A. S. (2011), Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. International Forum of Allergy & Rhinology, 1: 23–32. doi: 10.1002/alr.20020
- Issue published online: 25 FEB 2011
- Article first published online: 8 FEB 2011
- Manuscript Accepted: 5 OCT 2010
- Manuscript Revised: 17 SEP 2010
- Manuscript Received: 23 AUG 2010
- functional endoscopic sinus surgery;
Inflammation/polyp recurrence, adhesions, and middle turbinate lateralization are causes of suboptimal outcomes following sinus surgery and lead to increased rates of revision. A bioabsorbable, drug-eluting stent was evaluated for its ability to preserve sinus patency by providing controlled steroid delivery to the sinus mucosa. The study objective was to assess safety and efficacy of a steroid-eluting sinus stent when used following functional endoscopic sinus surgery (FESS) in patients with chronic rhinosinusitis (CRS).
Prospective, multicenter, randomized, double-blind clinical trial, enrolling 43 patients in 2 groups. One group (n = 38) used an intrapatient control design comparing drug-eluting to non-drug-eluting stents. The other group (n = 5) received bilateral drug-eluting stents to assess systemic safety. Endoscopic follow-up was performed for 60 days. Efficacy endpoints included assessment of inflammation, polyp formation, adhesions, and middle turbinate position.
Stents were successfully deployed in all 86 sinuses. Compared to the control stent, the drug-eluting stent provided statistically significant reduction in inflammation at days 21 to 45 (p < 0.003), frequency of polyp formation (p = 0.0391), and frequency of significant adhesion (p = 0.0313). Reduced frequency of middle turbinate lateralization was also apparent though not statistically significant. No device-related adverse events occurred. Eluted steroid was unquantifiable systemically and there was no evidence of adrenal cortical suppression.
This study demonstrates the safety and efficacy of a novel bioabsorbable, steroid-eluting stent for use in CRS patients. The steroid-eluting stent is effective in improving wound healing by preserving sinus patency, reducing inflammation, and minimizing adhesions via controlled local steroid delivery without measurable systemic exposure. © 2011 ARS-AAOA, LLC.