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Results of a new balloon dilation device study in the ENT market have been released. The ASCEND drug-coated sinus balloon from Intersect ENT is currently in investigational use only by federal law. The devices safety and efficacy were evaluated through a randomized, double-blind, multi-center trial. The ASCEND device was tested against an uncoated balloon to determine whether or not it would help reduce post-balloon dilation edema by delivering a localized steroid to the dilated tissue. The drug coated balloon for sinus dilation from Intersect ENT did not meet frontal sinus patency grade at day 30 of the study.
Boris Karanfilov, M.D., director of the Ohio Sinus Institute stated that “an initial observation worth noting from the results of this study is the trend for the mometasone furoate to significantly minimize inflammation and edema at the site of dilation when delivered with the ASCEND drug-coated balloon as compared to the uncoated balloon.” He further added that they “look forward to assessing the results of the study more extensively with our fellow clinical investigators and Intersect ENT.”
According to iData Research, the balloon dilation device market has experienced rapid growth in recent years. The ASP however, has decreased marginally in 2018 and is expected to continue. As competition grows, companies are forced to lower device prices to stay competitive. As with any successful novel technology, unit sales have experienced high growth in the past few years. This is completely driven by procedural growth and the broadening of reimbursement for these procedures. As Intersect ENT’s drug-coated balloon for sinus dilation device attempts to enter the market, it may positively contribute to growth if it can provide additional clinical study to receive PMA approval from the FDA.
President and CEO of Intersect ENT Tom West followed up by adding that his team “will continue to analyze the ASCEND study findings to inform our clinical and regulatory strategy. We remain committed to leading innovation with clinical evidence for the benefit of clinicians and patients with chronic sinusitis.”
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