Intersect ENT has started a blinded, multi-center, prospective, randomized clinical study, Resolve, of its new steroid delivery implant for treating patients with recurrent sinus obstruction.
The implant, which is designed as an alternative to oral steroid therapy or revision sinus surgery, delivers mometasone furoate steroid into the lining of sinus to dilate the re-obstructed sinus and resolve inflammation.
The device, which has more radial strength than the PROPEL and PROPEL mini dissolvable steroid-releasing implants, releases the steroid over a longer period of time, claims the company.
The trial will enroll 100 patients to evaluate the safety and effectiveness of steroid-eluting implant in patients with polyps, which recur in up to 60% of patients following endoscopic sinus surgery and are the leading cause for revision surgery.
Intersect ENT president and CEO Lisa Earnhardt said, "The reception from the physician community to localized steroid delivery and our PROPEL family of implants has been extraordinary, and we’re proud to be partnering with leading clinicians on RESOLVE to further expand the treatment options for sinus sufferers."