Intersect ENT (NSDQ:XENT) said today that it won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses.
The Menlo Park, Calif.-based company’s portfolio of steroid-releasing implants are used in patients undergoing ethmoid, frontal or maxillary surgeries to treat chronic sinusitis.
“The approval of Propel Contour adds a 3rd product under the Propel umbrella, expanding our offering of steroid releasing implants to improve surgical outcomes,” president & CEO Lisa Earnhardt said in prepared remarks. “With its strong clinical evidence, we expect that Propel Contour will extend adoption of our sinus implants both in the operating room as well as in the office, and that offering physicians a wide range of products to customize treatment based on their patients’ disease and anatomy will ultimately lead to broader overall usage.”
Data from an 80-patient study supported the implant’s approval, according to Intersect. The Progress study, which evaluated the safety and efficacy of the implant following surgery, met its primary efficacy endpoint and demonstrated a statistically significant relative reduction in the need for post-operative interventions compared to surgery alone.
“The introduction of Propel steroid releasing implants has led to meaningful benefits in how we as surgeons manage our patients, especially by reducing our reliance on oral steroids to prevent post-operative complications,” study investigator Dr. Robert Weiss added. “With Propel Contour, we are able to offer those benefits to a significant range of our chronic sinusitis patients, regardless of their unique anatomy, and to do so with the comfort of the same rigorous clinical evidence for which the Propel family of products is known. With this base of solid evidence pointing to a clear benefit, there are strong reasons to include Propel as part of standard clinical practice.”