Safety and efficacy of the PROPEL™ Steroid-Releasing Implant has been studied in three prospective clinical trials conducted in the United States, with a total of 205 patients enrolled.

• A randomized, controlled, double-blind Pilot study, recognized with the 2010 Maurice Cottle Research Award honoring best clinical or basic science by the American Rhinologic Society (ARS)
• The ADVANCE single-cohort study that assessed safety, endoscopic outcomes and patient symptoms to 6 months
• The ADVANCE II randomized, controlled, double-blind clinical trial, which included review by an independent panel of surgeons

All three trials assessed the safety and efficacy of controlled delivery of mometasone furoate to the ethmoid sinus mucosa via dissolvable implants in chronic rhinosinusitis (CRS) patients undergoing functional endoscopic sinus surgery (FESS). These rigorously designed studies provide an unparalleled level of clinical evidence upon market release for a sinus product. PROPEL brings clinically and statistically significant benefits to patients.

All studies were conducted in a challenging patient population:

• > 60% polyps at baseline
• > 30% prior sinus/nasal surgery
• > 12 Mean Lund-Mackay CT stage

Our clinical program has shown that PROPEL:

• Maintains patency by reducing post-operative adhesions, inflammation, polyposis11 & middle turbinate lateralization; Reducing these post-op factors is proven to improve long term outcomes and reduce the need for revision surgery12
• Decreases need for post-operative medical and surgical therapies, including adhesion lysis and oral steroid therapy

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Safety:

• Ocular safety demonstrated: No clinically significant changes from baseline in intraocular pressure or lens opacities occurred
• Systemic safety demonstrated: No evidence of systemic steroid exposure or adrenal-pituitary axis suppression

Meta-Analysis:

The Meta-analysis pooled the Pilot study and ADVANCE II results, which were both prospective, controlled randomized, double-blind, multi-center clinical trials with similar demographics and endpoints. The pooled analysis included 143 patients, who served as their own controls. The analysis assessed PROPEL’s ability to preserve sinus patency and reduce medical and surgical interventions after FESS.

• First Level 1-A evidence demonstrating the benefit of localized steroid release in the post-FESS period
• PROPEL's localized controlled steroid delivery confers meaningful benefits: Reduces adhesions, frank polyposis and middle turbinate lateralization. Reducing these post-op factors is proven to reduce the need for revision surgery12 PROPEL provided a 46% reduction in frank polyposis.11
• PROPEL improves surgical outcomes: Reduces need for post-operative medical and surgical therapies by 35%, which may mean shorter and less painful post-op visits. The analysis demonstrated a 40% reduction in need for oral steroid interventions11.

11 Han JK, Marple BF, Smith TL, et al. Presented at AAOA meeting Sept. 9, 2011

12 Kennedy et al. Laryngoscope. 110 (Suppl. 94):29–31, 2000

13 Murr AH, Smith TL, Hwang PH, et al. Int Forum Allergy Rhinol. 2011

14 Forwith KD, Chandra RK, Yun PT, et al. Laryngoscope, 121:2473–2480, 2011.