Entellus Medical (ENTL) Announces Publication of Positive XprESS Balloon SDS Study Data
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Entellus Medical, Inc. (Nasdaq: ENTL) announced that the results of a prospective, multicenter clinical study using the Company’s XprESS balloon sinus dilation system in pediatric patients were published in the peer reviewed journal International Forum of Allergy & Rhinology.
The clinical study evaluated fifty pediatric patients suffering from chronic rhinosinusitis (CRS): 33 patients between the ages of 2 and 12 years old, 17 patients older than 12. All patients, who had previously failed medical management, were treated with Entellus Medical’s XprESS Multi-Sinus Dilation System with follow-up conducted at one-, three-, and six-months post procedure. Outcome highlights of the study include:
- 157 sinus dilations were attempted and all were successful;
- No complications occurred in the study;
- Significant improvement in the Sinus and Nasal Quality Life Survey (SN-5) was seen for all pediatric patients between baseline and 6 months, 92% improved by a minimal clinically important difference (MCID) of 1.0 or more;
- Multivariate regression analysis showed no differences or associations of SN-5 improvement at 6 months with the presence of allergy, asthma, or concomitant procedures; and
- Overall 22-item Sino-Nasal Outcome Test (SNOT-22) mean scores were also significantly improved at 6 months for patients between the ages of 12 and 21.
"The study demonstrates that balloon sinus dilation can be performed safely and successfully on children 2 years and older with CRS,” said Zachary M. Soler, MD, MSc, Medical University of South Carolina. “When chosen correctly, children do appear to have improvements in quality of life up to 6 months following the procedure.”
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