Intersect ENT (NSDQ:XENT) announced today that it received CE mark approval for its Propel Contour sinus implant.
Menlo Park, Calif.-based Intersect ENT designed its Propel Contour sinus implant to maintain patency and reduce inflammation while conforming to the sinus ostia (openings) through mechanical support and steroid delivery where needed to optimize sinus surgery outcomes.
Propel Contour represents the third localized drug delivery implant in Intersect ENT’s Propel family of drug-eluting, bioabsorbable implants available in Europe, according to a news release.
The implant features an hourglass shape designed for placement in the frontal sinuses after sinus surgery to treat people with chronic rhinosinusitis. It also contains a low-profile, flexible delivery system to make it easier to access areas of the frontal sinus ostia.
Approval comes on the back of positive data from the Propel Contour cohort of a U.S. clinical study of 80 patients. The study met its primary efficacy endpoint, demonstrating a statistically significant 65% relative reduction in the need for post-operative interventions, including the need for additional surgical procedures or the need for oral steroid prescription, compared to surgery alone plus standard of care. Intersect ENT observed zero implant-related serious adverse events in the clinical studies.
“We are pleased that Propel Contour, the latest addition to the Propel family of steroid-releasing sinus implants, is now available in select EU countries to treat patients undergoing sinus surgeries, which represent the majority of procedures for the treatment of chronic rhinosinusitis,” Intersect ENT president & CEO Thomas A. West said in the release. “Our goal is to offer sinus physicians the broadest range of products so they can customize treatment for each patient with focused drug delivery and mechanical support where it is needed to optimize sinus surgery outcomes.
“The introduction of Contour is consistent with our strategic growth initiatives, where we expect to see more significant revenue contributions from Propel and our other technology platforms across Europe over the coming years.”