The low-profile flexible delivery system of the implant enables to easily access areas of the frontal sinus ostia
The Contour CE approval expands the portfolio of PROPEL products available for commercialisation. (Credit: NakNakNak from Pixabay)
Medical technology firm Intersect ENT has secured CE mark approval for its PROPEL Contour (mometasone furoate) sinus implant to treat patients with chronic rhinosinusitis following frontal sinus surgery.
The company has specifically designed the PROPEL Contour device to maintain patency and reduce inflammation, as well as conform to the sinus ostia (openings) by offering mechanical support and steroid delivery.
The Contour CE mark approval will allow the company to expand its portfolio of PROPEL products available for commercialisation, including PROPEL and PROPEL Mini.
Intersect ENT stated that PROPEL Contour is the third localised drug delivery implant and completes the PROPEL family of drug-eluting and bioabsorable implants currently available to ENT specialists in select EU countries.
Featuring an advanced hourglass shape, PROPEL Contour has been designed for placement in the frontal sinuses (between the eyebrows) following sinus surgery for chronic rhinosinusitis patients.
The implant is provided with a low-profile flexible delivery system to help easily access areas of the frontal sinus ostia.
Intersect ENT president and CEO Thomas West said: “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.”
The CE mark approval was based on positive data from the PROPEL Contour cohort of the US clinical study called PROGRESS.
The prospective, randomised, blinded and multi-centre trial recruited 80 patients to evaluate the safety and efficacy of the implant when placed in the frontal sinus ostia following endoscopic sinus surgery (ESS) with traditional instrumentation, balloon dilation or a combination of both.
According to the company, the trial achieved its primary efficacy endpoint by showing a statistically significant 65% relative reduction in the need for post-operative interventions.