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 t...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Pre-Market Approval (PMA) Regulatory/Compliance Surgical Intersect ENT Inc. Source Type: news