A new study published in JAMA Otolaryngology – Head & Neck Surgery details the successful trial of a novel implant that allows anti-inflammatory drugs to treat the frontal sinus tissue in patients with chronic sinusitis. The implant, said co-author Ameet Singh, MD, associate professor of surgery and of neurological surgery at the George Washington University (GW) School of Medicine and Health Sciences, offers a more localized treatment method and improves outcomes following endoscopic frontal sinus surgery.
Patients with chronic sinusitis experience symptoms such as nasal drainage, congestion, facial pain or pressure, and loss of smell for periods of at least three months.
“The frontal sinus has been the most challenging of the paranasal sinuses to keep open after endoscopic sinus surgery,” Singh explained. “This is due to its hourglass shape and its propensity to scar and become inflamed.”
The first drug dissolving implant was originally developed for use in the ethmoid sinus—located in the upper nasal cavity between the eye sockets—but was redesigned to fit in the opening, or ostia, of the frontal sinus, solving some of the challenges head and neck surgeons like Singh experience. The team conducted a multicenter, randomized trial of the new bioabsorbable steroid-releasing implant, with patients enrolled at the GW site.
The research team found that the implant was not only safe, but also reduced the need for post-operative surgical intervention when compared with frontal sinus surgery not followed by the implant.
The nine-month trial was led by Amber Luong, MD, PhD, at McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth) and sponsored by Intersect ENT, a manufacturer of drug delivery devices used by ear, nose, and throat clinicians in the treatment of sinusitis. The data from this trial was used to obtain FDA approval for the CONTOUR frontal sinus implant.
The next step, said Singh, “is to continue clinical work with the implant and determine which patients with chronic frontal sinusitis it is best suited for.”
Read “Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia" at JAMA Network.
