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.
About
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.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We may, in some cases, use terms such as “look forward,” "confident,” “promises,” “predicts,” “believe,” “potential,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on Intersect ENT’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation those related to the safety, efficacy and patient and physician adoption of the company’s products and therapies, the ability to obtain and maintain reimbursement codes for its products, the company’s ability to procure and maintain required regulatory approvals for our products, the company’s ability to grow and expand its business, as well as other risks detailed from time to time in Intersect ENT’s filings with the
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i Albu S. (2020). Chronic Rhinosinusitis-An Update on Epidemiology, Pathogenesis and Management. Journal of clinical medicine, 9(7), 2285. https://doi.org/10.3390/jcm9072285.
ii Javanbakht, M., Saleh, H., Hemami, M.R. et al. A Corticosteroid-Eluting Sinus Implant Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis: A
iii Metson RB, Gliklich RE. Clinical outcomes in patients with chronic sinusitis. Laryngoscope. 2000;110(3 Pt 3):24–8.
iv
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