Localized steroid-releasing sinus implant designed to maintain sinus opening now available in select EU countries
PROPEL Contour features an innovative hourglass shape, specifically designed for placement in the frontal sinuses (between the eyebrows) following sinus surgery for chronic rhinosinusitis patients. The implant features a low-profile flexible delivery system to make it easier to access areas of the frontal sinus ostia.
“Having the ability to accommodate the size and variable shape of the frontal sinus openings with the PROPEL Contour sinus implant is a great advantage for ENT specialists who treat patients suffering from chronic rhinosinusitis,” said Prof. Dr.
Chronic rhinosinusitis is one of the most common chronic medical conditions worldwide, affecting all age groups, with an estimated incidence of nearly 11% in
“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,” said
The CE Mark 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 when placed in the frontal sinus ostia, following endoscopic sinus surgery (ESS) with traditional instrumentation, balloon dilation, or a combination of both. The study met its primary efficacy endpoint, demonstrating a statistically significant 65 percent relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or the need for oral steroid prescription, compared to surgery alone + standard of care. There were no implant related serious adverse events reported in the clinical studies. The most common adverse reactions observed in > 2% of subjects were acute sinusitis, asthma, headache, chronic sinusitis, upper respiratory tract infection, fungal sinusitis, nasopharyngitis, nausea, neck pain, sinus headache and streptococcal pharyngitis.
For additional information on the Company or the products including risks and benefits please visit www.IntersectENT.com. For more information about PROPEL® (mometasone furoate) sinus implants and SINUVA® (mometasone furoate) sinus implant, please visit www.IntersectENT.de and www.SINUVA.com.
IMPORTANT SAFETY INFORMATION FOR PROPEL® SINUS IMPLANTS
The PROPEL Contour sinus implant is intended for use in patients ≥ 18 years of age with chronic rhinosinusitis following sinus surgery to maintain patency of the frontal sinus ostia and to locally deliver mometasone furoate to the sinus mucosa. The PROPEL Contour sinus implant separates/dilates mucosal tissues, prevents obstruction by adhesions/scarring, and reduces edema. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. For more information on the risks and benefits of PROPEL sinus implants, please visit www.intersectENT.com/products. For use by healthcare professionals only.
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