Drug-Eluting Sinus Stent Hits the Market: May help maintain patency after FESS

In 2009, Acclarent (Menlo Park, Calif.) introduced the Relieva Stratus as a way to address sinus mucosal inflammation. An article in Operative Techniques in Otolaryngology described the Stratus as a “drug-eluting sinus stent … for [the] minimally invasive treatment of chronic ethmoid mucosal disease” (2009;20(2):108-113). But in a departmental newsletter published in 2008, Dr. Citardi said the device is more like a “leaky balloon” than a traditional stent (UT ORL Update. 2008). That’s because the stent is filled with triamcinolone acetate, a local anti-inflammatory agent, and emits the drug over a two- to four-week period, at which time the device is removed in the office setting (Op Tech Otolaryngol Head Neck Surg. 2009;20(2):108-113). At least one case of orbital violation following placement of the drug-eluting ethmoid stent has been reported in the literature (Int Forum Allergy Rhinol [published online ahead of print August 26, 2011]).

Enter Propel

Despite many different interventions and surgical techniques, recurrent polyposis, inflammation, adhesion formation, middle turbinate lateralization and stenosis of surgically enlarged sinus ostia remain common problems following sinus surgery. Typical post-operative measures, such as the lysis of surgical adhesions or local or systemic anti-inflammatory treatment, are time consuming and present the potential for complications. Systemic anti-inflammatory treatment, though potentially effective, exposes patients to unnecessary system-wide effects.

Bradley Marple, MD, professor and vice chairman of the department of otolaryngology-head and neck surgery at the University of Texas Southwestern Medical Center at Dallas, discussed these challenges, as well as the potential of the Propel stent, in September at the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) annual meeting in San Francisco. Unlike previous sinus stents, he said at the meeting, Propel mechanically props the sinus ostia open while delivering mometasone furoate directly to the sinus mucosa over a 30-day period.

“A lot of the focus has been on the issue of sustained drug delivery, but the device, by virtue of expanding, holds the structures within the nose in an appropriate position to help prevent scarring and movement of structures that could cause problems, such as lateralization of the middle turbinate,” Dr. Marple said in a post-meeting phone interview.

To date, three clinical research trials have examined Propel: a randomized, double-blind pilot study (Int Forum Allergy Rhinol. 2011;1(1):23-32), the ADVANCE safety study and ADVANCE II, a randomized, double-blind clinical trial. Dr. Marple presented the ADVANCE II at the AAO-HNS annual meeting. Joseph K. Han, MD, an associate professor of rhinology and director of the divisions of allergy and rhinology and sinus-skull base surgery at Eastern Virginia Medical School in Norfolk, presented a meta-analysis of the data at the same meeting. Publication is pending on the meta-analysis data.