Intersect ENT, Inc. announced publication of results of the PROPEL® mini cohort of the PROGRESS study in The Laryngoscope. PROGRESS was a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of the PROPEL® mini steroid releasing sinus stent when used following frontal sinus surgery with standard postoperative care.
The study met its primary efficacy endpoint, demonstrating a statistically significant 38 percent relative reduction in the need for post-operative interventions (p=0.007) at 30 days compared to surgery alone with standard post-operative care. Post-operative interventions included the need for additional surgical procedures and/or need for oral steroids.
Clinical investigators also reported a 54 percent relative reduction in restenosis, a 56 percent relative reduction in the need for oral steroids, and a 75 percent relative reduction in the need for surgical interventions on sides treated with PROPEL mini compared to surgery alone at 30 days. The device placement success rate was 100% and there were no device-related adverse events.
In March 2016 Intersect ENT received approval for an expanded indication from the U.S. Food and Drug Administration (FDA) for placement of PROPEL mini in the frontal sinuses, which are located behind the eyebrows.
“The results from the PROGRESS study are important because they demonstrate that PROPEL mini improves the outcomes of frontal sinus surgery when added to standard postoperative care in chronic sinusitis patients with frontal sinus disease undergoing sinus surgery,” said Randall Ow, M.D. of Sacramento Ear, Nose, and Throat, a lead enroller in the study. “The recent expanded indication for PROPEL mini was much anticipated because the frontal sinus is more difficult to operate on and to manage post-operatively, compared to the other sinuses.”
More than 100,000 U.S. patients have been treated with PROPEL and PROPEL mini.