Intersect ENT wins expanded FDA approval for Propel Mini

Intersect ENT (NSDQ:XENT) said today 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 Menlo Park, Calif.-based 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.

“This approval is significant for patients with frontal sinus disease, which has traditionally been difficult to treat and greatly impacts quality of life, with debilitating symptoms including severe headaches. We are grateful to the patients who participated in the PROGRESS trial. The clinical data from the study are compelling for a large majority of patients with chronic frontal sinusitis and clearly illustrate the improved clinical outcomes for frontal sinus surgery patients treated with Propel mini,” study investigator Dr. Ameet Singh of George Washington University School of Medicine said in prepared remarks.

“This expanded use of Propel mini is a significant step in furthering our mission to improve the quality of life for sinus sufferers and lower the overall cost of patient care. We are thrilled that patients with frontal sinusitis – which we estimate affects 25 to 30 percent of patients undergoing surgery for chronic sinusitis – can join the more than 100,000 patients to date who have received treatment with Propel,” CEO Lisa Earnhardt said in a press release.

Last November, Intersect ENT said that budget impact data on its Propel steroid releasing implant for treating chronic sinusitis showed upfront costs offset by savings post-operatively.

The study reported that using propel had a “negligible impact” of -3¢ to 2¢ per member per month for self-insured employers or U.S. commercial payors.

Upfront cost was offset by savings associated with reduced post-operative inflammation and scarring probabilities and their treatment costs, the Menlo Park, Calif.-based company said.

Intersect ENT said refractory chronic sinusitis results in productivity costs to employers of over $10,000 per patient annually due to lost work days.

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