XENT - Intersect ENT receives CE Mark approval for PROPEL Contour sinus implant
Intersect ENT (XENT) has received CE Mark approval for the company’s PROPEL Contour (mometasone furoate) sinus implant enabling sales and distribution in the European Union.PROPEL Contour is specifically designed to maintain patency and reduce inflammation, and conform to the sinus openings.The approval was supported by positive data from the PROPEL Contour cohort of the US clinical study - PROGRESS, a prospective, randomized, blinded, multi-center trial of 80 patients designed to assess the safety and efficacy of the implant.The study met its primary efficacy endpoint, showing a statistically significant 65% relative reduction in the need for post-operative interventions, compared to surgery alone + standard of care.
For further details see:
Intersect ENT receives CE Mark approval for PROPEL Contour sinus implant