“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.
Intersect ENT’s PROPEL products are the first and only dissolvable steroid releasing sinus implants approved by the U.S. Food and Drug Administration. Clinically proven to improve outcomes for chronic sinusitis patients following sinus surgery, PROPEL sinus implants mechanically prop open the sinuses and release mometasone furoate, an advanced corticosteroid with anti-inflammatory properties, directly into the sinus lining then dissolve. PROPEL’s safety and effectiveness for use in ethmoid sinuses is supported by Level 1-A clinical evidence from multiple clinical trials, which demonstrates that PROPEL implants reduce inflammation and scarring after ethmoid sinus surgery, thereby reducing the need for post-operative oral steroids and repeat surgical interventions. PROPEL is indicated for the ethmoid sinus; PROPEL Mini is indicated for the ethmoid and frontal sinuses; and PROPEL Contour is indicated for the frontal and maxillary sinuses.
Intersect ENT is dedicated to transforming ear, nose and throat care by providing innovative, clinically meaningful therapies to physicians and patients. 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 localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care.
Intersect ENT and PROPEL are registered trademarks of Intersect ENT Inc.
ASCEND is an investigational drug-device combination and is not available for sale in the United States.