Intersect ENT, Inc., a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced publication of a pooled analysis in the International Forum of Allergy & Rhinology, the official journal of the American Rhinologic Society, of the company's PROPEL® Contour and PROPEL® Mini steroid releasing sinus implants showing improved outcomes of frontal sinus surgery.
The analysis included a total of 160 patients enrolled in two clinical trial cohorts. Patients were randomized following sinus surgery to receive an implant in one frontal sinus ostium with the contralateral ostium as control.
The pooled analysis showed that the PROPEL frontal steroid releasing implants significantly improve endoscopic outcomes of frontal sinus surgery compared to surgery alone. The use of implants resulted in a relative reduction in the need for postoperative interventions of 46.8% at Day 30. A significant reduction in postoperative interventions was also observed at Day 90. There were no implant-related adverse events.
"Frontal sinus surgery in patients with chronic rhinosinusitis has historically been associated with poorer outcomes than that of the other paranasal sinuses" said Ameet Singh, M.D., Division of Otolaryngology at George Washington University Medical Center and lead author of the study. "This analysis provides important insights into outcomes in various patient subgroups and also demonstrates that PROPEL implants improve the outcomes of frontal sinus surgery by reducing the need for post-operative interventions through 90 days."
Placed following endoscopic sinus surgery, the PROPEL family of implants is designed to maintain the surgical opening and prop open the sinus ostia while delivering drug directly to the sinus lining as the implant dissolves.
"We are very pleased to see the positive findings of this study added to the robust pool of clinical evidence supporting our steroid releasing implants," said Lisa Earnhardt, president and CEO, Intersect ENT. "We're delighted that the PROPEL family of implants continues to be a strong, evidence-based option for ENTs seeking improved outcomes for patients following sinus surgery."