Intersect ENT of Menlo Park, California has received FDA approval for its PROPEL Contour steroid releasing sinus implant, which is indicated for treatment of chronic sinusitis in the frontal and maxillary sinuses. Besides providing structural integrity, it reduces the need for orally administered steroids and only supplies them where needed.
The PROPEL Contour is delivered compacted using a flexible placement system and expanded to fill the anatomy. The device’s hourglass shape is designed to match the sinus ostia, helping to maintain patency following a surgical procedure.
A bit of detail about the study that led to this approval:
Positive data from the PROPEL Contour cohort of 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, supported the approval. The study met its primary efficacy endpoint, demonstrating a statistically significant 65 percent relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or the need for oral steroid prescription, compared to surgery alone.
Link: Intersect ENT homepage…
Via: Intersect ENT…
