Intersect ENT, Inc., a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, announced that the company has submitted a supplemental premarket approval submission (PMA-s) to the FDA to seek approval for its new NOVA steroid-releasing implant for patients with chronic sinus disease.
NOVA’s unique hourglass shape and lower profile is designed to allow for placement in smaller sinus openings, and may expand the applicable patient population for steroid-releasing implants.
The NOVA cohort of the PROGRESS study was a prospective, randomized, blinded, multi-center trial of 80 patients designed to assess the safety and efficacy of the implant when placed in the frontal sinuses following surgery. As previously announced, the study met its primary efficacy endpoint, demonstrating a statistically significant 65% 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 with standard post-operative care. The device placement success rate was 100 percent and there were no device-related adverse events through 90-day follow-up.
“This submission is another important milestone in our efforts to address unmet needs for chronic sinusitis patients across the continuum of care,” said Lisa Earnhardt, president and CEO, Intersect ENT. “NOVA’s design, which allows for placement in smaller sinus openings, has the potential to be an important option for physicians treating and managing chronic sinus disease.”