Intersect ENT (NSDQ:XENT) said today that its Resolve sinus implant met both primary endpoints in the Resolve II pivotal trial.
The Menlo Park, Calif.-based company’s Resolve steroid-releasing sinus implant is a minimally invasive treatment for patients with recurrent ethmoid sinus obstruction. The 300-patient Resolve II trial compared the bilateral Resolve implant with a sham procedure.
The study evaluated the change in polyp grade after 90 days using video endoscopy, showing a statistically significant reduction for patients receiving the implant. The treatment group also experienced a reduction in sense of nasal obstruction and congestion. There was a single incidence of intranasal bleeding, a serious adverse event.
Intersect ENT said it plans to use the data to back its bid for FDA approval of the device.
“The Resolve II study outcomes are compelling, and the medical community is eager to embrace new treatment options such as this less invasive procedure that can easily be performed in a physician’s office,” Dr. Robert Kern, of Chicago’s Northwestern Medical Center, said in prepared remarks. “The study results suggest that Resolve has the potential to improve quality of life while allowing patients to avoid additional surgical procedures.”
“This is a significant milestone in our history and for our future as we look to dramatically expand the impact we have across the continuum of care for sinusitis sufferers,” added president & CEO Lisa Earnhardt. “The Resolve product offers a less-invasive and potentially more cost-effective solution for this challenging patient population. As part of our commitment to evidence-based innovation, we look forward to taking the next step toward bringing Resolve to ENT physicians and their patients.”