Intersect ENT has reported the preliminary results of a Progressive study, which is designed to evaluate the safety and efficacy of the Propel mini steroid releasing sinus implant when used following frontal sinus surgery.
According to the firm, the trial met its primary efficacy endpoint showing a statistically significant 38% relative reduction in the need for post-operative interventions such as the need for additional surgical procedures or need for oral steroid prescription compared to surgery alone.
Intersect ENT president and CEO Lisa Earnhardt said: "We are pleased with the positive outcomes from Progress, which bring us another step closer to broadening access to sustained local steroid delivery to more patients suffering from chronic sinusitis.
"Our next step will be to compile and submit the results to the FDA this year."
The prospective, randomized, blinded and multi-center trial is intended to support an expanded indication for placement of Propel mini in the frontal sinuses that are located behind the eyebrows.
The firm’s Propel and Propel mini are claimed to be the first and only steroid releasing sinus implants that obtained FDA approval for use in patients following ethmoid sinus surgery.
Both products release mometasone furoate, a steroid with anti-inflammatory properties, directly into the sinus lining and then dissolve. Propel is said to maintain the open passages created in surgery, avoiding the need for oral steroids and additional surgical procedures.