This webpage contains information on investigational devices and drugs. These products are limited by Federal (U.S.) law to investigational use. Intersect ENT makes no claims of safety or effectiveness of these unapproved investigational products. The intent of presenting this information is to convey research and development initiatives underway at Intersect ENT.
The investigational RESOLVE steroid releasing implant is designed to be placed during a physician office visit to provide a minimally invasive treatment option for patients with recurrent ethmoid sinus obstruction that would otherwise warrant revision surgery. The RESOLVE implant is designed to release mometasone furoate directly into the sinus lining to target inflammation. It was designed with greater radial strength than the PROPEL products in order to dilate an obstructed sinus and releases steroid over a longer period of time to reduce inflammation. The RESOLVE implant is investigational and is not available for commercial use anywhere.
Four clinical studies of the RESOLVE implant have been conducted over the past five years, including a pilot study of 12 patients to evaluate feasibility of placement, a pharmacokinetic study of five patients, the RESOLVE randomized controlled trial of 100 patients evaluating both safety and efficacy, and the recently completed RESOLVE II Phase III randomized controlled trial of 300 patients.
To learn about the latest news regarding RESOLVE, please download our press release.