The Food and Drug Administration (FDA) has approved the Propel Contour dissolvable steroid-releasing sinus implant (Intersect ENT) for the treatment of patients with chronic sinusitis in the frontal and maxillary sinuses to improve outcomes following sinus surgery. The implant contains mometasone furoate, a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties.
Propel Contour features an hourglass design and is specifically designed to conform to the sinus ostia, focusing drug delivery and mechanical support where it is needed in order to maximize sinus surgery outcomes. The implant features a low-profile flexible delivery system to make it easier to access tight areas of the sinus anatomy.
The approval was based on the PROGRESS study, a prospective, randomized, blinded, multi-center trial of 80 patients designed to assess the safety and efficacy of the implant when placed in the frontal sinuses following surgery. The study met its primary efficacy endpoint, demonstrating a statistically significant 65% relative reduction in the need for post-operative interventions (eg, additional surgery, oral steroids), compared to surgery alone.
The company expects to launch Propel Contour broadly in the second quarter of 2017.
For more information visit Intersectent.com.