FDA to Review Novel Steroid-Releasing Implant for Chronic Sinus Disease
Intersect ENT announced the submission of a supplemental premarket approval (PMA-s) to the Food and Drug Administration for its novel, bioabsorbable steroid-releasing implant, NOVA, for patients with chronic sinus disease.
NOVA was investigated in the PROGRESS study, a multicenter, prospective, randomized, blinded trial evaluating the safety and efficacy of the implant when placed in the frontal sinuses in 80 patients post surgery. The study met its primary endpoint, showing that NOVA achieved a statistically significant 65% relative reduction in the need for post-operative interventions, including additional surgical procedures or steroid prescription, compared to surgery alone with standard post-operative care. No device-related adverse events were observed throughout the study.
NOVA is an investigational steroid-releasing implant designed for placement in the smaller sinus openings, due to its unique hourglass shape and lower profile, to deliver anti-inflammatory medication post surgical interventions.
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