FDA Approves Intersect ENT’s Propel for Expanded Indication

FDA has approved an Intersect ENT PMA supplement a for an expanded indication for its Propel mini steroid releasing sinus implant to treat patients undergoing frontal sinus surgery. The approval allows the company to market the device for implanting in the frontal sinuses, located behind the eyebrows. Previously, it was indicated for placement in the ethmoid sinuses, located just behind the bridge of the nose. Approval was based on data from the PROGRESS study, which demonstrated a statistically significant (38%) relative reduction in the need for post-operative interventions compared to surgery alone. Additional statistically significant results, according to the company, included a 75% relative reduction in the need for surgical intervention, a 56% relative reduction in the need for oral steroids and a 54% relative reduction in frontal sinus restenosis.