Erratum: Controlled steroid delivery via[b] bioabsorbable stent: Safety and performance in a rabbit model

Safety and efficacy of a novel bioabsorbable, steroid‐eluting sinus stent

“…The choice of sampling 5 patients for this safety assessment was not statistically based on a power calculation but was determined based upon clinical judgment and the knowledge that in previous rabbit studies, plasma MF levels were extremely low and in many samples, not quantifiable. 5 Additional exclusionary criteria for these subjects were use of MF in any form within 2 weeks of sinus surgery or during follow-up to day 30. These subjects underwent a series of blood sampling to assess plasma MF and cortisol concentrations over time.…”

“…This polymer is a common biomedical substance that is used in many types of FDA-approved medical devices including suture material and, as shown in prior animal studies, does not incite an inflammatory response. 5 A total dose of 370 μg of MF is blended into the polymer structure of polylactide-co-glycolide, which releases the MF by diffusion in a controlled fashion over approximately 30 days. The stent is self-expanding, allowing it to conform to the varying sizes and shapes of the ethmoid sinus.…”

“…17 However, the use of systemic steroids also carries with it the potential for steroid-related complications such as aseptic necrosis of the femoral head, calcium demineralization, posterior cataract formation, mood disorders, and difficulty in controlling blood glucose levels in patients with diabetes. 23 Li et al 5 have previously reported on the use of a bioabsorbable stent in a rabbit model that eluted mometasone furoate (MF). This stent has the potential to combine the function of enhancing surgical results through the prevention of synechiae and stenosis of the surgical cavity with the beneficial properties of delivering corticosteroid to the surgical cavity with minimal potential for drug-related complications.…”

“…3 Devices designed to counteract the tendency for scarring and synechiae formation are ubiquitous and include stents, packing, sponges, and gels. [4][5][6][7] All were conceived in an attempt to enhance surgical success.…”

International Consensus Statement on Allergy and Rhinology: Rhinosinusitis

“…In animal studies, this stent showed minimal mucosal inflammatory reaction. 1316 The Propel TM stent has been investigated in 1 cohort and 2 RCTs, which have demonstrated its efficacy and safety. All 3 studies found similar outcomes in improvements in symptom scores and endoscopic findings (decreased polyposis and adhesions) as well need for postoperative intervention when compared to the stent without corticosteroids.…”