Intersect ENT has obtained CE marking for the PROPEL Contour sinus implant (mometasone furoate), facilitating its marketing and supply in the EU.
The implant is designed to preserve patency, reduce inflammation, and accommodate osties or sinus openings via mechanical support as well as steroid administration in cases requiring improved results of the sinus procedure.
A common medical condition, chronic rhinosinusitis affects people of all ages around the world. About 15% of chronic sinusitis patients in the UK undergo surgery if therapy fails each year.
Excessive drainage of mucus, nasal obstruction, breathing problems, pain and tenderness around the eyes, cheeks, nose and forehead, decreased smell and taste, as well as fatigue and irritability are some of the symptoms of chronic sinusitis.
In addition, these patients have lower quality of life scores compared to other common chronic diseases, such as congestive heart failure, angina pectoris, chronic obstructive pulmonary disease, and back pain.
PROPEL Contour has an hourglass shape to allow positioning in the frontal sinuses between the eyebrows after sinus surgery in patients with chronic rhinosinusitis.
The implant includes a low profile flexible delivery system for easy access to the frontal sinus ostias.
The latest approval expands PROPEL’s product portfolio of drug-eluting bioabsorbable implants, which currently includes PROPEL and PROPEL Mini available on the market.
Thomas West, CEO of Intersect ENT, said: “Our goal is to offer sinus physicians the widest range of products so they can customize treatment for each patient with targeted drug delivery and mechanical support. where it is needed to optimize the results of sinus surgery.
“The introduction of Contour is consistent with our strategic growth initiatives, where we expect to see greater revenue contributions from PROPEL and our other technology platforms across Europe over the next few years.
The CE mark approval is based on positive data from the PROPEL Contour cohort from the PROGRESS clinical study in the United States.
This prospective, randomized, blinded, multicenter study evaluated the safety and efficacy of the implant placed in the frontal sinus ostia after endoscopic sinus surgery in 80 subjects.