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Intersect ENT receives CE Mark for PROPEL Contour for patients with chronic rhinosinusitis following frontal sinus surgery

Press releases may be edited for formatting or style | May 20, 2021

"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 Thomas A. West, President and Chief Executive Officer of Intersect ENT. "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 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.

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About Intersect ENT
Intersect ENT is a global ear, nose and throat medical technology leader dedicated to transforming patient care. The Company's steroid releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the Company's unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care. In October 2020, Intersect ENT acquired Fiagon AG Medical Technologies, a global leader in electromagnetic surgical navigation solutions with an expansive portfolio of ENT product offerings, including the VenSure sinus dilation balloon, which is FDA-approved in the US that complement the Company's PROPEL® and SINUVA® sinus implants and extend its geographic reach.

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