Intersect ENT announced that they have submitted a supplemental premarket approval submission (PMA-s) to the U.S. Food and Drug Administration (FDA) to seek approval for its new NOVA steroid releasing implant for patients with chronic sinus disease.
The investigational NOVA steroid releasing implant is designed to prop sinuses open mechanically while delivering anti-inflammatory medication following surgical interventions, such as sinus surgery in the operating room or sinus dilation in the physician’s office.
NOVA’s 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.
The study met its primary efficacy endpoint, demonstrating a statistically significant 65 percent 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.
“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,” said Lisa Earnhardt, president and CEO, Intersect ENT.
NOVA has not been approved by the FDA and is available for investigational use only.