Intersect ENT Announces First Patient Enrolled in ASCEND Study of Investigational Drug-Coated Sinus Balloon
Posted on December 17, 2018 by Medtech[y] Staff
Intersect ENT ($XENT) today announced the enrollment of the first patient in the company’s study of its newest platform product, the ASCEND investigational drug-coated sinus balloon. This novel device is designed to deliver a corticosteroid (mometasone furoate) directly to the sinuses at the time of dilation.
“We are excited to begin enrollment in this study of our fifth product leveraging our expertise in localized drug delivery, and we believe that this product, if approved, would be complementary to our current product offerings,” said Lisa Earnhardt, president and CEO of Intersect ENT. “This is an important milestone for Intersect ENT, and illustrates our continued commitment to developing innovative solutions for sinus patients.”
The study will assess whether the ASCEND product can reduce inflammation by delivering a steroid directly to the dilated tissue while opening narrowed passageways in the sinuses. Balloons are currently used in approximately 200,000 sinus procedures annually in the United States. If successful, the product would be reviewed under the PMA pathway.
The ASCEND study is a prospective, randomized, blinded, multi-center trial of 70 patients that will assess the safety and efficacy of Intersect ENT’s drug-coated sinus balloon. The ASCEND drug-coated sinus balloon will be randomized against an uncoated balloon. Similar to the clinical studies for the PROPEL® family of steroid releasing sinus implants, the primary endpoint will be evaluated at 30 days. The study will assess the device’s ability to improve patency rates, as well as a number of other endoscopic parameters.
“The ASCEND study will aim to assess the potential benefits of directed drug delivery at the time of balloon dilation, a potential advance beyond the current treatment paradigm,” said Boris Karanfilov, M.D., Director of the Ohio Sinus Institute, who serves as national Principal Investigator of the study.