Intersect ENT Propel study finds efficacy in frontal sinus surgery

Intersect ENT (NSDQ:XENT) said a new study of its Propel mini steroid-releasing sinus implant used after frontal sinus surgery met endpoints and returned positive results.

The Propel device is already approved for use in the ethmoid sinuses behind the bridge of the nose in conjunction with sinus surgery to treat symptoms of chronic sinusitis, the company said.

The study reported the device met its primary efficacy endpoint with a 38% relative reduction in the need for post operative interventions and device placement was successful in 100% of patients with no device-related adverse events, Intersect ENT said.

“Frontal sinus disease contributes greatly to the debilitating symptoms of chronic sinusitis, including severe headaches, and is known to be the most difficult sinus to manage. These results offer an exciting prospect for this group of patients,” principal investigator Dr. Tim Smith of Oregon Health and Science University said in a press release.

The trial is intended to support an expanded indication for Propel for use in the frontal sinuses located behind the eyebrows, which Intersect ENT said they would submit an application for this year.

“We are pleased with the positive outcomes from Progress, which bring us another step closer to broadening access to sustained local steroid delivery to more patients suffering from chronic sinusitis. Our next step will be to compile and submit the results to the FDA this year,” CEO Lisa Earnhardt said in prepared remarks.

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