Entellus Medical Reports Presentation of Study Results for XpreESS in Pediatric Patients

Entellus Medical, Inc.

announced today that Dr. Zachary M. Soler, MD, MSc, Medical University of South Carolina, presented the results of a prospective, multicenter study of children with chronic rhinosinusitis (CRS) treated with the XprESS™ Multi-Sinus Dilation System. The results were presented at the Combined Otolaryngology Spring Meetings (COSM) in Chicago, Illinois. The study was designed as a prospective, multicenter investigation. Fifty children, 2-21 years old, with chronic rhinosinusitis (CRS) who had failed medical management were treated with Entellus Medical's XprESS Multi-Sinus Dilation System and followed to six months post procedure. Primary outcomes were technical success and complication rates. Secondary outcomes included mean change in quality of life scores, percent achieving a minimal clinically important difference (MCID), and revision surgery rate. Highlights of the results include: 157 sinus dilations were attempted and all 157 attempts (100%) were successful No complications Significant improvement in the Sinus and Nasal Quality of Life Survey [SN-5] was seen between baseline and 6 months and 92% of patients improved by the MCID of 1.0 or more Multivariate regression analysis indicated there were no differences or associations of improvement based on presence of allergy, asthma, or concomitant procedures For adolescents, mean overall Sino-Nasal Outcome Test-22 [SNOT-22] scores were also significantly improved at 6 months The revision procedure rate was 0% Dr. Soler noted, "Results of this study demonstrate that children with chronic sinusitis significantly improve after balloon dilation of the sinuses. When medical treatment fails, balloon dilation should be considered a viable treatment option for properly selected patients, particularly those desiring a less invasive approach." Based on the positive outcomes of this study, Entellus received 510(k) clearance from the FDA for use of its XprESS Multi-Sinus Dilation System in pediatric patients in November 2015. This clearance expands the patient population to include treatment of maxillary sinuses in patients 2 years and older, and treatment of the frontal and sphenoid sinuses in patients 12 years and older. Entellus Medical is the only company to have received FDA clearance for balloon sinus dilation to treat the frontal and sphenoid sinuses in adolescents.