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% 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.”
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 unique hourglass shape and lower profile is designed for placement in the smaller sinus openings, which may expand the applicable patient population for steroid releasing implants. NOVA has not been approved by the FDA and is available for investigational use only.
Intersect ENT, Inc. is dedicated to improving the quality of life for patients with ear, nose and throat conditions. The company markets two steroid releasing implants, PROPEL and PROPEL mini, which have been clinically proven to improve surgical outcomes for chronic sinusitis patients undergoing sinus surgery.
