Intersect ENT has obtained CE mark for PROPEL Contour (mometasone furoate) sinus implant, facilitating its marketing and supply in the EU.
The implant is designed to preserve patency, lessen inflammation and adapt to the sinus ostia or openings via mechanical support as well as the delivery of steroids in cases requiring enhanced sinus procedure outcomes.
A common medical condition, chronic rhinosinusitis affects people of all ages globally. Approximately 15% of chronic sinusitis patients in the UK undergo surgery upon failing therapies every year.
Excessive mucus drainage, nasal blockage, breathing problems, pain and tenderness around the eyes, cheeks, nose and forehead, a diminished smell and taste sense, and fatigue and irritability are some of the symptoms of chronic sinusitis.
Furthermore, these patients experience lower quality of life scores when compared to other common chronic diseases, such as congestive heart failure, angina, chronic obstructive pulmonary disease and back pain.
PROPEL Contour has an hourglass shape to enable 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 to facilitate easy access to the frontal sinus ostia areas.
The latest approval broadens the PROPEL product portfolio of drug-eluting, bioabsorbable implants, which currently includes PROPEL and PROPEL Mini available in the market.
Intersect ENT president and CEO Thomas West said: “Our goal is to offer sinus physicians the broadest range of products so they can customise treatment for each patient with focused drug delivery and mechanical support where it is needed to optimise 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 is based on positive data from the PROPEL Contour cohort of PROGRESS clinical study in the US.
This prospective, randomised, blinded, multi-centre trial evaluated the safety and efficacy of the implant placed in the frontal sinus ostia after endoscopic sinus surgery in 80 subjects.