Intersect ENT (NSDQ:XENT) said today it submitted a supplemental premarket approval submission to the FDA seeking approval for a new Nova steroid releasing implant for treating patients with chronic sinus disease.
The new Nova device is designed with a lower profile to allow for placement in smaller sinus openings, and will expand the usable patient population for the steroid releasing implants, the Menlo Park, Calif.-based company said.
“This submission is another important milestone in our efforts to address unmet needs for chronic sinusitis patients across the continuum of care. Nova 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,” CEO Lisa Earnhardt said in a press release.
A cohort from the company’s Progress study examined the use of the Nova device in 80 patients, which met its primary efficacy endpoint and reported a 65% relative reduction in the need for additional surgical procedures or oral steroid prescriptions. Device placement rate was 100% during the trial, with no device-related adverse events through a 90-day follow up.
In March, Intersect ENT said it won FDA premarket approval for an expanded indication for its Propel mini steroid releasing sinus implant designed to treat patients undergoing frontal sinus surgery.
The expanded indication from the company will allow the company to market the placement of the Propel mini in the frontal sinuses behind the eyebrows. Previous indication only allowed for placement in the ethmoid sinuses behind the bridge of the nose.